<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/NCT03249935</url>
  </required_header>
  <id_info>
    <org_study_id>16-0002</org_study_id>
    <secondary_id>HHSN272201300012I</secondary_id>
    <nct_id>NCT03249935</nct_id>
  </id_info>
  <brief_title>YCFM (Youth Correctional Facilities Males)</brief_title>
  <official_title>Treatment Failure and Associated Predictors Following Azithromycin Treatment for Urogenital Chlamydial Infection in Males in Youth Correctional Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the&#xD;
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is&#xD;
      designed primarily to determine the frequency of chlamydia treatment failure following&#xD;
      azithromycin in males who do versus do not have urethral symptoms of urethral discharge&#xD;
      and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,&#xD;
      with subject participation duration of 28 days and study duration of 4 years. The primary&#xD;
      objective of the study is to assess the microbiological efficacy of azithromycin in&#xD;
      uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms&#xD;
      in YCFs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a single center (with multiple long-term YCFs) treatment trial of the&#xD;
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males residing in&#xD;
      long-term gender-segregated YCFs. This study is designed primarily to determine the frequency&#xD;
      of chlamydia treatment failure following azithromycin in males who do versus do not have&#xD;
      urethral symptoms of urethral discharge and/or dysuria. Males age 12 to 21 years in good&#xD;
      health (based on vital signs and provider's clinical evaluation documented in medical&#xD;
      records) who are residing in long-term gender-segregated (not co-ed) YCFs (usual stay &gt; 3&#xD;
      weeks) and who are identified as chlamydia-infected comprise the study population. The&#xD;
      anticipated enrollment is 446 males with subject participation duration of 28 days and study&#xD;
      duration of 4 years. The primary objective of the study is to assess the microbiological&#xD;
      efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with&#xD;
      versus without urethral symptoms in YCFs; in essence, this study will assess the frequency of&#xD;
      chlamydia treatment failure to azithromycin at the Day 28 follow-up visit (Visit 2) in males&#xD;
      with urethral symptoms compared to males without urethral symptoms. The secondary objective&#xD;
      is to evaluate the association of laboratory findings (enrollment chlamydia load and OmpA&#xD;
      genotype) and other participant characteristics (demographics, sexual behaviors, etc.) to&#xD;
      chlamydia treatment failure in males after azithromycin treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Actual">September 17, 2018</completion_date>
  <primary_completion_date type="Actual">September 17, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms</measure>
    <time_frame>Day 28-follow-up visit</time_frame>
    <description>Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment</measure>
    <time_frame>Day 28-follow-up visit</time_frame>
    <description>Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Chlamydial Infection</condition>
  <arm_group>
    <arm_group_label>Azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azithromycin 1 gm PO single dose given as directly observed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Azithromycin 1 gm PO single dose given as directly observed</description>
    <arm_group_label>Azithromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no&#xD;
        co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C.&#xD;
        trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at&#xD;
        least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study&#xD;
        procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1.Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT&#xD;
        2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to&#xD;
        azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due&#xD;
        to use of azithromycin 5.Having received antimicrobial therapy with activity against C.&#xD;
        trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval&#xD;
        between the positive screening NAAT and study enrollment 6.Any concomitant infection, which&#xD;
        requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled&#xD;
        in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment,&#xD;
        that prohibits subject from enrolling in study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Los Angeles County Department of Health Services - Juvenile Court Health Services</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>September 12, 2019</results_first_submitted>
  <results_first_submitted_qc>October 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2019</results_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Azithromycin</keyword>
  <keyword>Chlamydia</keyword>
  <keyword>Correctional</keyword>
  <keyword>Facilities</keyword>
  <keyword>Symptoms</keyword>
  <keyword>Urethral</keyword>
  <keyword>Urogenital</keyword>
  <keyword>Youth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Chlamydia Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</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>October 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03249935/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Azithromycin</title>
          <description>Azithromycin 1 gm PO single dose given as directly observed&#xD;
Azithromycin: Azithromycin 1 gm PO single dose given as directly observed</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Discharged from facility early</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Negative for chlamydia at enrollment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants who tested positive for chlamydia at baseline.</population>
      <group_list>
        <group group_id="B1">
          <title>Azithromycin</title>
          <description>Azithromycin 1 gm PO single dose given as directly observed&#xD;
Azithromycin: Azithromycin 1 gm PO single dose given as directly observed</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.0" lower_limit="15.2" upper_limit="18.9"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </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="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms</title>
        <description>Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.</description>
        <time_frame>Day 28-follow-up visit</time_frame>
        <population>Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable at day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>Symptomatic</title>
            <description>Symptomatic was defined as urethral discharge and/or dysuria at baseline.</description>
          </group>
          <group group_id="O2">
            <title>Asymptomatic</title>
            <description>Asymptomatic was defined as not having urethral discharge or dysuria at baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms</title>
          <description>Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.</description>
          <population>Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable at day 28.</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="12"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <other_analysis_desc>Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment</title>
        <description>Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.</description>
        <time_frame>Day 28-follow-up visit</time_frame>
        <population>Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable for treatment failure at day 28.</population>
        <group_list>
          <group group_id="O1">
            <title>Azithromycin</title>
            <description>Azithromycin 1 gm PO single dose given as directly observed Azithromycin: Azithromycin 1 gm PO single dose given as directly observed</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment</title>
          <description>Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.</description>
          <population>Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable for treatment failure at day 28.</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="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.656</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.22</ci_lower_limit>
            <ci_upper_limit>2.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.197</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>47.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After study drug administration (Study Visit 1) through the Day 28 follow-up visit (Study Visit 2).</time_frame>
      <desc>Gastrointestinal AEs that occur after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will be recorded. AEs which cause a participant to discontinue from the study after study drug administration (Study Visit 1) and through the Day 28 follow-up visit (Study Visit 2) will also be recorded.</desc>
      <group_list>
        <group group_id="E1">
          <title>Azithromycin</title>
          <description>Azithromycin 1 gm PO single dose given as directly observed&#xD;
Azithromycin: Azithromycin 1 gm PO single dose given as directly observed</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="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="5" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </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>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>
    <limitations_and_caveats>In September 2018, the decision was made to stop enrollment early due to changes in the LA Public Health and YCF standard facility management systems; research staff were not able to overcome the resulting challenges making enrollment infeasible.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jeannette Lee</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>501-526-6712</phone>
      <email>jylee@uams.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/NCT03249935
org study id: 16-0002
secondary id: HHSN272201300012I
nct id: NCT03249935
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is
      designed primarily to determine the frequency of chlamydia treatment failure following
      azithromycin in males who do versus do not have urethral symptoms of urethral discharge
      and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,
      with subject participation duration of 28 days and study duration of 4 years. The primary
      objective of the study is to assess the microbiological efficacy of azithromycin in
      uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms
      in YCFs.
The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
      CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males residing in
      long-term gender-segregated YCFs. This study is designed primarily to determine the frequency
      of chlamydia treatment failure following azithromycin in males who do versus do not have
      urethral symptoms of urethral discharge and/or dysuria. Males age 12 to 21 years in good
      health (based on vital signs and provider's clinical evaluation documented in medical
      records) who are residing in long-term gender-segregated (not co-ed) YCFs (usual stay > 3
      weeks) and who are identified as chlamydia-infected comprise the study population. The
      anticipated enrollment is 446 males with subject participation duration of 28 days and study
      duration of 4 years. The primary objective of the study is to assess the microbiological
      efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with
      versus without urethral symptoms in YCFs; in essence, this study will assess the frequency of
      chlamydia treatment failure to azithromycin at the Day 28 follow-up visit (Visit 2) in males
      with urethral symptoms compared to males without urethral symptoms. The secondary objective
      is to evaluate the association of laboratory findings (enrollment chlamydia load and OmpA
      genotype) and other participant characteristics (demographics, sexual behaviors, etc.) to
      chlamydia treatment failure in males after azithromycin treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms
time frame: Day 28-follow-up visit
description: Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.
measure: Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment
time frame: Day 28-follow-up visit
description: Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.
arm group label: Azithromycin
arm group type: Experimental
description: Azithromycin 1 gm PO single dose given as directly observed
intervention type: Drug
intervention name: Azithromycin
description: Azithromycin 1 gm PO single dose given as directly observed
arm group label: Azithromycin
criteria: 
gender: Male
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Chlamydia Infections
mesh term: Azithromycin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In September 2018, the decision was made to stop enrollment early due to changes in the LA Public Health and YCF standard facility management systems; research staff were not able to overcome the resulting challenges making enrollment infeasible.
point of contact: 