<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/NCT03275623</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-17-0294</org_study_id>
    <nct_id>NCT03275623</nct_id>
  </id_info>
  <brief_title>Management of Sub-Clinical Bacteriuria in Pregnancy</brief_title>
  <official_title>Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if treatment of pregnant women with urine cultures&#xD;
      with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease&#xD;
      adverse pregnancy outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Have Cystitis</measure>
    <time_frame>about 10 months</time_frame>
    <description>Cystitis is defined as a urine culture with &gt;100,000 CFU at any point during antenatal care.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Have Pyelonephritis</measure>
    <time_frame>about 10 months</time_frame>
    <description>Pyelonephritis is defined as a urine culture with &gt;100,000 CFU with fever at any point during antenatal care.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cystitis</condition>
  <condition>Cystitis;Puerperium</condition>
  <condition>Pyelonephritis</condition>
  <arm_group>
    <arm_group_label>Antibiotic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No antibiotic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antibiotic</intervention_name>
    <description>Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.</description>
    <arm_group_label>Antibiotic treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Prenatal Care</intervention_name>
    <description>Continued surveillance of urinary cultures</description>
    <arm_group_label>Antibiotic treatment</arm_group_label>
    <arm_group_label>No antibiotic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women who seek prenatal care within the University of Texas Health System&#xD;
             with UT Physicians.&#xD;
&#xD;
          -  Urine culture of less than 100,000 CFU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Risk factors to complicated UTI (including but not limited to: diverticula,&#xD;
             urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent&#xD;
             placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux,&#xD;
             ileal conduit)&#xD;
&#xD;
          -  Use of immunosuppressant drugs&#xD;
&#xD;
          -  Abnormalities of the urinary tract (including but not limited to: known ureteric or&#xD;
             urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction,&#xD;
             congenital anomalies, history of urological procedures)&#xD;
&#xD;
          -  History of renal disease including renal failure and transplants&#xD;
&#xD;
          -  Urine culture &gt; 100,000 CFU of any organism&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Akwugo A Eziefule, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</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>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <results_first_submitted>March 19, 2020</results_first_submitted>
  <results_first_submitted_qc>March 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 3, 2020</results_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Akwugo Adanna Eziefule</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteriuria</mesh_term>
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Pyelonephritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</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>August 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03275623/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Antibiotic Treatment</title>
          <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
        </group>
        <group group_id="P2">
          <title>No Antibiotic Treatment</title>
          <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Antibiotic Treatment</title>
          <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
        </group>
        <group group_id="B2">
          <title>Antibiotic Treatment</title>
          <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20-34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=35</title>
              <category_list>
                <category>
                  <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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Have Cystitis</title>
        <description>Cystitis is defined as a urine culture with &gt;100,000 CFU at any point during antenatal care.</description>
        <time_frame>about 10 months</time_frame>
        <population>2 participants in the &quot;no antibiotic treatment&quot; arm and 5 in the &quot;antibiotic treatment&quot; arm were not assessed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>No Antibiotic Treatment</title>
            <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
          </group>
          <group group_id="O2">
            <title>Antibiotic Treatment</title>
            <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Have Cystitis</title>
          <description>Cystitis is defined as a urine culture with &gt;100,000 CFU at any point during antenatal care.</description>
          <population>2 participants in the &quot;no antibiotic treatment&quot; arm and 5 in the &quot;antibiotic treatment&quot; arm were not assessed for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Have Pyelonephritis</title>
        <description>Pyelonephritis is defined as a urine culture with &gt;100,000 CFU with fever at any point during antenatal care.</description>
        <time_frame>about 10 months</time_frame>
        <population>2 participants in the &quot;no antibiotic treatment&quot; arm and 5 in the &quot;antibiotic treatment&quot; arm were not assessed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>No Antibiotic Treatment</title>
            <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
          </group>
          <group group_id="O2">
            <title>Antibiotic Treatment</title>
            <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Have Pyelonephritis</title>
          <description>Pyelonephritis is defined as a urine culture with &gt;100,000 CFU with fever at any point during antenatal care.</description>
          <population>2 participants in the &quot;no antibiotic treatment&quot; arm and 5 in the &quot;antibiotic treatment&quot; arm were not assessed for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during antenatal care (about 10 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>No Antibiotic Treatment</title>
          <description>Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</description>
        </group>
        <group group_id="E2">
          <title>Antibiotic Treatment</title>
          <description>Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.&#xD;
Antibiotic: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.&#xD;
Standard Prenatal Care: Continued surveillance of urinary cultures</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Jerrie S. Refuerzo, MD</name_or_title>
      <organization>The University of Texas Health Science Center at Houston</organization>
      <phone>(713) 500-6416</phone>
      <email>Jerrie.S.Refuerzo@uth.tmc.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/NCT03275623
org study id: HSC-MS-17-0294
nct id: NCT03275623
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the study is to determine if treatment of pregnant women with urine cultures
      with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease
      adverse pregnancy outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Have Cystitis
time frame: about 10 months
description: Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.
measure: Number of Participants Who Have Pyelonephritis
time frame: about 10 months
description: Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.
arm group label: Antibiotic treatment
arm group type: Active Comparator
description: Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
arm group label: No antibiotic treatment
arm group type: Active Comparator
description: Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
intervention type: Drug
intervention name: Antibiotic
description: Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.
arm group label: Antibiotic treatment
intervention type: Other
intervention name: Standard Prenatal Care
description: Continued surveillance of urinary cultures
arm group label: Antibiotic treatment
arm group label: No antibiotic treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Akwugo A Eziefule, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Akwugo Adanna Eziefule
investigator title: Staff Physician
mesh term: Bacteriuria
mesh term: Cystitis
mesh term: Pyelonephritis
mesh term: Anti-Bacterial Agents
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 