<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/NCT03231228</url>
  </required_header>
  <id_info>
    <org_study_id>HC-G-H-1601</org_study_id>
    <nct_id>NCT03231228</nct_id>
  </id_info>
  <brief_title>Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects</brief_title>
  <official_title>Phase 4, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Safety of 1 g of Cefazolin in Pediatric Subjects Weighing 25 to Less Than 60 kg and 2 g of Cefazolin in Pediatric Subjects Weighing at Least 60 kg Scheduled for Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of&#xD;
      cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive)&#xD;
      scheduled for surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1&#xD;
      ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60&#xD;
      kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg&#xD;
      will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or&#xD;
      gender. Additional subjects may be enrolled if necessary to ensure at least 50 evaluable&#xD;
      subjects with complete safety data per dose group complete the study.&#xD;
&#xD;
      In a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the&#xD;
      cefazolin plasma concentrations in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped with agreement from FDA.&#xD;
  </why_stopped>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>n/a, this is an open label study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events [Safety]</measure>
    <time_frame>8 days</time_frame>
    <description>Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cefazolin Plasma Concentration Following Infusion</measure>
    <time_frame>Up to 4 hours after start of study drug infusion</time_frame>
    <description>Concentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Postoperative Infection</condition>
  <arm_group>
    <arm_group_label>Cefazolin 1 g Infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cefazolin 2 g Infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin 1 g Infusion</intervention_name>
    <description>1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
    <arm_group_label>Cefazolin 1 g Infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin 2 g Infusion</intervention_name>
    <description>2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</description>
    <arm_group_label>Cefazolin 2 g Infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is between the ages of 10 and 17 years (inclusive) at the time of giving&#xD;
             informed consent.&#xD;
&#xD;
          2. The subject is scheduled for surgery that will last less than 3 hours.&#xD;
&#xD;
          3. The subject and the subject's legally authorized representative voluntarily agree that&#xD;
             the subject will participate in this study. In accordance with applicable laws,&#xD;
             regulations, and institutional review board requirements, the subject signs or orally&#xD;
             agrees to an age-appropriate assent and the subject's legally authorized&#xD;
             representative signs both an institutional review board approved informed consent form&#xD;
             and Health Insurance Portability and Accountability Act authorization prior to the&#xD;
             performance of any screening procedures.&#xD;
&#xD;
          4. For subjects who agree to participate in the PK subgroup additional consent will be&#xD;
             obtained.&#xD;
&#xD;
          5. The subject weighs (on Day 1) ≥25 kg but &lt;60 kg for inclusion in 1 g dose group.&#xD;
&#xD;
          6. The subject weighs (on Day 1) ≥60 kg for inclusion in 2 g dose group.&#xD;
&#xD;
          7. The subject has been scheduled for any type of surgery requiring single dose&#xD;
             perioperative cefazolin prophylaxis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or lactating/breastfeeding.&#xD;
&#xD;
          2. Female subjects of childbearing potential who are sexually active and who are not&#xD;
             willing to use an effective method of birth control during the study period, eg, oral&#xD;
             contraceptives, double barrier methods, hormonal injectable or implanted&#xD;
             contraceptives, tubal ligation, or have a partner with a vasectomy.&#xD;
&#xD;
          3. The subject has impaired renal function based on the revised Schwartz formula.&#xD;
&#xD;
          4. The subject has a known allergy or hypersensitivity to β lactam/cephalosporin&#xD;
             antibiotics, penicillins, corn products, or dextrose containing products or solutions,&#xD;
             or any of the other ingredients of Cefazolin for Injection United States Pharmacopeia&#xD;
             (USP) and Dextrose Injection USP in DUPLEX.&#xD;
&#xD;
          5. The subject has abnormal vital signs or an abnormal electrocardiograph (ECG)&#xD;
             considered by the investigator to be clinically significant.&#xD;
&#xD;
          6. The subject has a result of any laboratory test (or repeat test, if done), obtained as&#xD;
             standard of care, that is outside the normal limit of the site's laboratory reference&#xD;
             range AND is considered by the investigator to be clinically significant.&#xD;
&#xD;
          7. The subject has a known history of human immunodeficiency virus, hepatitis B, or&#xD;
             hepatitis C infection.&#xD;
&#xD;
          8. The subject has a history of alcohol or drug abuse.&#xD;
&#xD;
          9. The subject has received any other investigational drug/device within 30 days prior to&#xD;
             the study drug administration.&#xD;
&#xD;
         10. The subject has a history of or is currently smoking or using nicotine-containing&#xD;
             substances or electronic cigarettes as determined by medical history or subject's&#xD;
             verbal report.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Research Institute</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health Care System</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf</url>
    <description>Ancef (cefazolin for injection) [package insert]. GlaxoSmithKline. Research Triangle Park (NC); 2004 [cited 2016 Jun 08]</description>
  </link>
  <link>
    <url>https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050779s025lbl.pdf</url>
    <description>Cefazolin and Dextrose for Injection [package insert]. B. Braun Medical Inc. Bethlehem [PA]; revised 10/2015</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <results_first_submitted>February 28, 2020</results_first_submitted>
  <results_first_submitted_qc>February 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2020</results_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cefazolin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03231228/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03231228/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Master ICF</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03231228/ICF_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: PK Master ICF</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03231228/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cefazolin 1 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.&#xD;
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
        </group>
        <group group_id="P2">
          <title>Cefazolin 2 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.&#xD;
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cefazolin 1 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.&#xD;
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
        </group>
        <group group_id="B2">
          <title>Cefazolin 2 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.&#xD;
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</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="33"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</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>&gt;=65 years</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>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="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.68" lower_limit="25.9" upper_limit="59.3"/>
                    <measurement group_id="B2" value="81.49" lower_limit="60.9" upper_limit="122.7"/>
                    <measurement group_id="B3" value="64.29" lower_limit="25.9" upper_limit="122.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events [Safety]</title>
        <description>Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.</description>
        <time_frame>8 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cefazolin 1 g Infusion</title>
            <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.&#xD;
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
          </group>
          <group group_id="O2">
            <title>Cefazolin 2 g Infusion</title>
            <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.&#xD;
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events [Safety]</title>
          <description>Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cefazolin Plasma Concentration Following Infusion</title>
        <description>Concentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.</description>
        <time_frame>Up to 4 hours after start of study drug infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cefazolin 1 g Infusion</title>
            <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.&#xD;
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
          </group>
          <group group_id="O2">
            <title>Cefazolin 2 g Infusion</title>
            <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.&#xD;
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</description>
          </group>
        </group_list>
        <measure>
          <title>Cefazolin Plasma Concentration Following Infusion</title>
          <description>Concentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.</description>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0.5 - 1.0 HR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.7" spread="33.880"/>
                    <measurement group_id="O2" value="145.5" spread="62.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 HR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.51" spread="14.399"/>
                    <measurement group_id="O2" value="93.26" spread="42.267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 HR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.35" spread="10.273"/>
                    <measurement group_id="O2" value="57.74" spread="24.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 HR</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.30" spread="6.0245"/>
                    <measurement group_id="O2" value="45.03" spread="20.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>39 Days maximum which includes maximum 30 days screening period through 8 days post-study drug administration</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cefazolin 1 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.&#xD;
Cefazolin 1 g Infusion: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to &lt;60 kg</description>
        </group>
        <group group_id="E2">
          <title>Cefazolin 2 g Infusion</title>
          <description>Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.&#xD;
Cefazolin 2 g Infusion: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post-Operative Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <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="13" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infusion site warmth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Catheter site bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infusion site bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication neurological</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Incision site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Vascular access site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Clumsiness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Following the first publication, the PI may publish data or results from the Study; provided that the PI submits the proposed publication to Sponsor for review at least sixty (60) days prior to the date of submission to the proposed publication. Sponsor may request that any Confidential Information be removed from the proposed publication other than Study data and results. The Investigator certifies that it shall not publish any Study related material other than per this agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Diana Valencia MD</name_or_title>
      <organization>B. Braun Medical Inc.</organization>
      <phone>610-596-2875</phone>
      <email>diana.valencia@bbraunusa.com</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/NCT03231228
org study id: HC-G-H-1601
nct id: NCT03231228
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of
      cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive)
      scheduled for surgery.
Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1
      ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60
      kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg
      will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or
      gender. Additional subjects may be enrolled if necessary to ensure at least 50 evaluable
      subjects with complete safety data per dose group complete the study.

      In a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the
      cefazolin plasma concentrations in this population.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.
primary purpose: Prevention
masking: None (Open Label)
masking description: n/a, this is an open label study
measure: Number of Participants With Treatment-Emergent Adverse Events [Safety]
time frame: 8 days
description: Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.
measure: Cefazolin Plasma Concentration Following Infusion
time frame: Up to 4 hours after start of study drug infusion
description: Concentrations will be determined through analysis of 4 blood samples drawn at 0.5-1, 2, 3, and 4 hours after the start of study drug infusion.
arm group label: Cefazolin 1 g Infusion
arm group type: Active Comparator
description: Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.
arm group label: Cefazolin 2 g Infusion
arm group type: Active Comparator
description: Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.
intervention type: Drug
intervention name: Cefazolin 1 g Infusion
description: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg
arm group label: Cefazolin 1 g Infusion
intervention type: Drug
intervention name: Cefazolin 2 g Infusion
description: 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
arm group label: Cefazolin 2 g Infusion
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50461slr139_ancef_lbl.pdf
description: Ancef (cefazolin for injection) [package insert]. GlaxoSmithKline. Research Triangle Park (NC); 2004 [cited 2016 Jun 08]
url: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050779s025lbl.pdf
description: Cefazolin and Dextrose for Injection [package insert]. B. Braun Medical Inc. Bethlehem [PA]; revised 10/2015
responsible party type: Sponsor
mesh term: Cefazolin
sharing ipd: No
provided document: 
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 