<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02223520</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00092982</org_study_id>
    <secondary_id>R01HS022872</secondary_id>
    <nct_id>NCT02223520</nct_id>
  </id_info>
  <brief_title>Treating Parents to Reduce NICU Transmission of Staphylococcus Aureus Trial</brief_title>
  <acronym>TREAT PARENTS</acronym>
  <official_title>Treating Parents to Reduce Neonatal Intensive Care Unit (NICU) Transmission of Staphylococcus Aureus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will test the hypothesis that treating parents of neonates requiring NICU care&#xD;
      with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S.&#xD;
      aureus from parents to neonates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a&#xD;
      placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that&#xD;
      treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine&#xD;
      gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to&#xD;
      the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be&#xD;
      pre-screened and parents will be approached for enrollment in the study. After consent and&#xD;
      baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a&#xD;
      parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment&#xD;
      with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo.&#xD;
&#xD;
      After recruitment and informed consent, parents will undergo pre-randomization screening. If&#xD;
      both parents screen negative for S. aureus colonization, the neonate will be ineligible for&#xD;
      the randomization and parents will be informed that the parents are not colonized at that&#xD;
      time with S. aureus. If either parent screens positive for S. aureus, then both parents as a&#xD;
      pair will be eligible for randomization to one of the two possible masked treatment arms. The&#xD;
      neonate-parent &quot;pair&quot; will be the unit of randomization and each parent will be allocated to&#xD;
      the same group if both consent.&#xD;
&#xD;
      After the baseline neonate testing for S. aureus colonization, repeat testing will be&#xD;
      performed every 7 days for the neonates until the neonate acquires S. aureus colonization or&#xD;
      is discharged from the NICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain</measure>
    <time_frame>Up to 90 days</time_frame>
    <description>Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">307</enrollment>
  <condition>Staph Aureus Colonization</condition>
  <condition>Staph Aureus Infection</condition>
  <arm_group>
    <arm_group_label>Mupirocin and Chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo ointment and placebo cloths</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mupirocin and Chlorhexidine</intervention_name>
    <arm_group_label>Mupirocin and Chlorhexidine</arm_group_label>
    <other_name>bactroban</other_name>
    <other_name>chlorhexidine gluconate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo ointment and placebo cloths</intervention_name>
    <arm_group_label>Placebo ointment and placebo cloths</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonate has never had a clinical or surveillance culture grow S. aureus&#xD;
&#xD;
          -  Neonate was transferred from another hospital or admitted from home and had admission&#xD;
             screening cultures for S. aureus colonization that were negative (if admission&#xD;
             cultures were not performed, the cultures will be performed as part of the&#xD;
             pre-randomization screening process)&#xD;
&#xD;
          -  Parent(s) is(are) able to visit the child at the bedside&#xD;
&#xD;
          -  Parent(s) test positive for S. aureus at screening&#xD;
&#xD;
          -  Neonate has anticipated stay longer than 5 days in the NICU (if estimated stay is&#xD;
             unclear, parents can be screened for S. aureus colonization and decision to randomize&#xD;
             can be delayed until hospital day 3 or 4 after reassessment of anticipated stay).&#xD;
&#xD;
          -  Parents is(are) willing to be randomized&#xD;
&#xD;
          -  No documented or reported allergies to any agent used in either treatment regimen&#xD;
&#xD;
          -  Able to perform written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to any agent used in either treatment regimen&#xD;
&#xD;
          -  Neonate has had a prior clinical or surveillance culture grow S. aureus&#xD;
&#xD;
          -  Neonate admitted to NICU from home and is greater than 7 days of age&#xD;
&#xD;
          -  Neonate admitted to NICU from another hospital and is greater than 7 days of age&#xD;
&#xD;
          -  Neonate is a ward of the State&#xD;
&#xD;
          -  Not able to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Milstone, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>March 2, 2020</results_first_submitted>
  <results_first_submitted_qc>March 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2020</results_first_posted>
  <last_update_submitted>January 7, 2022</last_update_submitted>
  <last_update_submitted_qc>January 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Staphylococcus aureus</keyword>
  <keyword>Infection</keyword>
  <keyword>Colonization</keyword>
  <keyword>Transmission</keyword>
  <keyword>Neonate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Mupirocin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT02223520/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mupirocin and Chlorhexidine</title>
          <description>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.&#xD;
Mupirocin and Chlorhexidine</description>
        </group>
        <group group_id="P2">
          <title>Placebo Ointment and Placebo Cloths</title>
          <description>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.&#xD;
Placebo ointment and placebo cloths</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="147"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="147">101 neonates of these parents were enrolled. 12 were lost to follow-up.</participants>
                <participants group_id="P2" count="160">107 neonates of these parents were enrolled. 6 were lost to follow-up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mupirocin and Chlorhexidine</title>
          <description>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.&#xD;
Mupirocin and Chlorhexidine</description>
        </group>
        <group group_id="B2">
          <title>Placebo Ointment and Placebo Cloths</title>
          <description>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.&#xD;
Placebo ointment and placebo cloths</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="147"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="307"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age of neonate at time of enrollment (days)</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.9" spread="5.1"/>
                    <measurement group_id="B2" value="7.2" spread="5.3"/>
                    <measurement group_id="B3" value="7.54" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Johns Hopkins Hospital</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Johns Hopkins Bayview</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parent age at the time of enrollment</title>
          <population>This is a measure for the parents. Parent demographics collected by parent interview or parent completion of form. Parents sometimes skipped questions on survey form and were not always available to capture missing demographic data that was not in the medical record.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="134"/>
                    <count group_id="B2" value="146"/>
                    <count group_id="B3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.3" spread="5.9"/>
                    <measurement group_id="B2" value="30.9" spread="7.7"/>
                    <measurement group_id="B3" value="30.6" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parent antibiotic use in past 6 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unreported/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parent history of mupirocin use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unreported/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parent history of Staphylococcus aureus infection</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unreported/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of education of parent</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="147"/>
                    <count group_id="B2" value="160"/>
                    <count group_id="B3" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>At most high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some or completed college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No. of singletons</title>
          <description>Neonates that were delivered as singletons.</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Birthweight of neonate</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1982.5" spread="972.8"/>
                    <measurement group_id="B2" value="1986.9" spread="949.4"/>
                    <measurement group_id="B3" value="1984.8" spread="958.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child delivery method</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Vaginal birth</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cesarean section</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Neonate inborn or transferred in</title>
          <description>Inborn was defined as neonates who were born at Johns Hopkins Hospital (JHH)/Johns Hopkins Bayview Medical Center (JHBMC) instead of being transferred to JHH/JHBMC from an outside hospital or home.</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Inborn in JHH/JHBMC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Transferred from another hospital to JHH/JHBMC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Transferred from home to JHH/JHBMC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age at birth</title>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.9" spread="4.7"/>
                    <measurement group_id="B2" value="33.1" spread="4.4"/>
                    <measurement group_id="B3" value="33" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal antibiotic use during delivery</title>
          <description>Neonates whose mothers reported using antibiotic during delivery.</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal Group B Streptococcus positive</title>
          <description>Neonates whose mothers reported testing positive for Group B Streptococcus.</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unreported/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Maternal HIV Positive</title>
          <description>Neonates whose mothers reported being positive for HIV.</description>
          <population>This baseline measure reported is for the neonates not the parents.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="101"/>
                    <count group_id="B2" value="107"/>
                    <count group_id="B3" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="186"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unreported/Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain</title>
        <description>Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.</description>
        <time_frame>Up to 90 days</time_frame>
        <population>This outcome is being assessed in the neonate population not the mothers. 12 of the neonates in the intervention group and 6 in the placebo group were lost to follow-up and could not be included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Mupirocin and Chlorhexidine</title>
            <description>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.&#xD;
Mupirocin and Chlorhexidine</description>
          </group>
          <group group_id="O2">
            <title>Placebo Ointment and Placebo Cloths</title>
            <description>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.&#xD;
Placebo ointment and placebo cloths</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain</title>
          <description>Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.</description>
          <population>This outcome is being assessed in the neonate population not the mothers. 12 of the neonates in the intervention group and 6 in the placebo group were lost to follow-up and could not be included in the analysis.</population>
          <units>neonatal S. aureus infections</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the 5 days of treatment</time_frame>
      <desc>Adverse events were assessed in mothers not neonates.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mupirocin and Chlorhexidine</title>
          <description>Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.&#xD;
Mupirocin and Chlorhexidine</description>
        </group>
        <group group_id="E2">
          <title>Placebo Ointment and Placebo Cloths</title>
          <description>Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.&#xD;
Placebo ointment and placebo cloths</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="147"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Retained placenta</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="147"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nose irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="147"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="147"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Aaron M. Milstone, M.D., M.H.S.</name_or_title>
      <organization>Johns Hopkins Medical Institutions</organization>
      <phone>410-614-3917</phone>
      <email>amilsto1@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02223520
org study id: NA_00092982
secondary id: R01HS022872
nct id: NCT02223520
lead sponsor: 
collaborator: 
has dmc: Yes
This trial will test the hypothesis that treating parents of neonates requiring NICU care
      with intranasal mupirocin and topical chlorhexidine bathing will reduce the spread of S.
      aureus from parents to neonates.
The TREAT PARENTS Trial, or Treating Parents to Reduce NICU Transmission of S. aureus, is a
      placebo-controlled, double-masked, randomized clinical trial to test the hypothesis that
      treatment of S. aureus colonized parents with intranasal mupirocin and topical chlorhexidine
      gluconate antisepsis will decrease neonatal S. aureus acquisition. All neonates admitted to
      the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center NICUs will be
      pre-screened and parents will be approached for enrollment in the study. After consent and
      baseline screening, 400 neonate-parent pairs will be randomized; only neonates who have a
      parent colonized with S. aureus will be randomized. Parents will receive a 5 day treatment
      with intranasal mupirocin plus topical chlorhexidine gluconate antisepsis or placebo.

      After recruitment and informed consent, parents will undergo pre-randomization screening. If
      both parents screen negative for S. aureus colonization, the neonate will be ineligible for
      the randomization and parents will be informed that the parents are not colonized at that
      time with S. aureus. If either parent screens positive for S. aureus, then both parents as a
      pair will be eligible for randomization to one of the two possible masked treatment arms. The
      neonate-parent "pair" will be the unit of randomization and each parent will be allocated to
      the same group if both consent.

      After the baseline neonate testing for S. aureus colonization, repeat testing will be
      performed every 7 days for the neonates until the neonate acquires S. aureus colonization or
      is discharged from the NICU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain
time frame: Up to 90 days
description: Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.
arm group label: Mupirocin and Chlorhexidine
arm group type: Active Comparator
description: Participants will apply 2% intranasal mupirocin twice a day for five days and cleanse with 2% chlorhexidine cloths once a day for five days.
arm group label: Placebo ointment and placebo cloths
arm group type: Placebo Comparator
description: Participants will apply 2% petrolatum intranasal placebo ointment twice a day for five days and cleanse with 2% non-medicated soap placebo cloths once a day for five days.
intervention type: Drug
intervention name: Mupirocin and Chlorhexidine
arm group label: Mupirocin and Chlorhexidine
other name: bactroban
other name: chlorhexidine gluconate
intervention type: Drug
intervention name: Placebo ointment and placebo cloths
arm group label: Placebo ointment and placebo cloths
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Milstone, MD, MHS
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Staphylococcal Infections
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Mupirocin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 