<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/NCT01661985</url>
  </required_header>
  <id_info>
    <org_study_id>Ostergotland CC</org_study_id>
    <nct_id>NCT01661985</nct_id>
  </id_info>
  <brief_title>Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced</brief_title>
  <official_title>Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ostergotland County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Statens Serum Institut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ostergotland County Council, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this on-going study is to study the number of days after antibiotic treatment&#xD;
      has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia&#xD;
      trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative&#xD;
      test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained&#xD;
      vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to&#xD;
      detect macrolide resistant Mg-strains and study whether there are any emerging macrolide&#xD;
      resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the&#xD;
      participating subjects are adherent to the study protocol meaning 12 samples taken during a&#xD;
      period of four weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mycoplasma genitalium (Mg), detected in 1980, causes a urogenital infection through sexual&#xD;
      transmission. In contrast to Chlamydia trachomatis antibiotic resistance is common against&#xD;
      tetracyclines and is emerging against macrolides such as azithromycin. Both antibiotics are&#xD;
      recommended as the first line treatment of chlamydia infection. Recent published data,&#xD;
      however, indicate that 1g azithromycin stat may be only bacteriostatic when treating&#xD;
      chlamydia.&#xD;
&#xD;
      The consensus to date is that there should always be a test of cure in pregnant women having&#xD;
      been treated for chlamydia and in all individuals treated for Mg.&#xD;
&#xD;
      There are no studies published, to our knowledge, where the time to eradication after&#xD;
      antibiotic treatment commenced in Mg infection has been evaluated. The first line treatment&#xD;
      of a confirmed Mg infection is azithromycin 1.5 g given during a period of 5 days. If&#xD;
      macrolide resistance is plausible or confirmed moxifloxacin 400mg for 7 to 10 days is&#xD;
      recommended.&#xD;
&#xD;
      Individuals with symptomatic urethritis or cervicitis and/or being sexual partners to&#xD;
      individuals being treated for a suspect or confirmed Mg or CT infection were eligible. The&#xD;
      study subjects were patients attending either of the STD-clinics in Norrköping or Västervik,&#xD;
      Sweden. All samples were sent to Statens Serum Institut(SSI), Mycoplasma department (Jorgen&#xD;
      Skov Jensen) for analysis.&#xD;
&#xD;
      Patients accepting enrolment with a confirmed or highly suspected Mg were receiving&#xD;
      azithromycin 500 mg the first day and 250mg the following four days.&#xD;
&#xD;
      Patients where macrolide resistant Mg-strain infection was highly suspected received&#xD;
      moxifloxacin 400 mg once daily for seven days.&#xD;
&#xD;
      Those subjects intended to treatment but with a lower degree of suspicion of Mg infection&#xD;
      were randomized to either a treatment with doxycycline 200 mg the first day and 100 mg once&#xD;
      daily the following nine days (the custom and recommendation in Sweden for treatment of&#xD;
      chlamydia and non-specific urethritis or cervicitis) OR a treatment with azithromycin 1g as a&#xD;
      single dose.&#xD;
&#xD;
      All participants were given test kits for 12 samples, which were to be sampled three times&#xD;
      weekly (every second day) during four weeks starting the day after the first day of&#xD;
      treatment. They were instructed not to have any sexual intercourse during the first week and&#xD;
      with condom afterwards during the study period. The samples were to be sent once weekly&#xD;
      (three samples)to SSI.The date of sampling was to be noted on the label of the tube and the&#xD;
      attaching paper to SSI, where also any symptoms were to be noted. The results of the tests&#xD;
      were sent to the STD-clinic who informed the patient.&#xD;
&#xD;
      The study started in February 2010 and inclusion of patients have ended for those subjects&#xD;
      with a verified M genitalium infection (February 2014), whereas patients with a verified or&#xD;
      suspected chlamydia infection still are enrolled and randomised to azithromycin 1 g or&#xD;
      doxycycline. A manuscript will soon be submitted concerning those subjects being treated for&#xD;
      a M genitalium infection.&#xD;
&#xD;
      To date 190 patients have been enrolled and also fulfilled the study protocol with sampling&#xD;
      of specimens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2010</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Time from treatment starts to date of first negative test result is achieved up to 30 days.</measure>
    <time_frame>From first day of treatment to date of first negative test up to 30 days per subject</time_frame>
    <description>Three arms. A randomisation (concealed envelopes) to either treatment with azithromycin 1g as a single dose or doxycycline for nine days (200 mg first day and 100 mg following nine (during summer time lymecycline 300mg twice daily for ten days). One un-randomized arm: Treatment with azithromycin 500 mg the first day and 250mg following four days or when indicated moxifloxacin 400 mg once daily for seven days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin</measure>
    <time_frame>One month after treatment has started</time_frame>
    <description>Quantitive pcr of chlamydia and Mg is used. All Mg strains are tested for mutant genes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number or rate of patients adherent regarding sampling according to the protocol</measure>
    <time_frame>One month after starting sampling</time_frame>
    <description>To describe whether the subjects are adherent to the study protocol according to doing the sampling and sending the samples correctly.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Urethritis</condition>
  <condition>Cervicitis</condition>
  <condition>Genital Mycoplasma Infection</condition>
  <condition>Chlamydia Trachomatis</condition>
  <arm_group>
    <arm_group_label>Drug: Azithromycin 1g</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Azithromycin 1 g,single dose (per os)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Doxycycline/lymecycline 9/10days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tetracycline either as Doxycycline or during June and July lymecycline (due to lower risk of photo-sensitivity) given for treatment in 9(10)days (per os).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Azithromycin 1.5 g</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients not randomized but receiving the first line treatment when a confirmed Mg infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>In the randomized arm giver orally 1 g as a single dose. In the non-randomized arm given for 5 days 250mg 2x1 first day and 1x1 following four days.</description>
    <arm_group_label>Azithromycin 1.5 g</arm_group_label>
    <arm_group_label>Drug: Azithromycin 1g</arm_group_label>
    <other_name>Zitromax</other_name>
    <other_name>Azitromax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline</intervention_name>
    <description>Doxycycline tablets 100 mg 2x1 the first day and 100 mg daily for following eight days (following the Swedish tradition and experience since the 1970s of treating chlamydia)</description>
    <arm_group_label>Drug: Doxycycline/lymecycline 9/10days</arm_group_label>
    <other_name>Doxyferm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lymecycline</intervention_name>
    <description>Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)</description>
    <arm_group_label>Drug: Doxycycline/lymecycline 9/10days</arm_group_label>
    <other_name>Tetralysal 300mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals attending the STD-clinic and being a sexual partner who has received an&#xD;
             antibiotic treatment due to a non-specific urethritis/cervicitis or a confirmed&#xD;
             Mycoplasma genitalium/Chlamydia trachomatis infection OR Having a confirmed infection&#xD;
             described above or a symptomatic urethritis or cervicitis (non-gonorrhoic)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy against any of the drugs, woman being pregnant or breast feeding, Not speaking&#xD;
             or understanding Swedish fluently. Other medication with possible interaction to given&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Falk, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Derm&amp;Venereology Linköping University hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lars Falk, MD PhD</last_name>
    <phone>+46 10 103 8507</phone>
    <email>lars.falk@lio.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jorgen S Jensen, MD DrMedSci</last_name>
    <email>jsj@ssi.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>R&amp;D dept of Local Health Care, Östergötland county council</name>
      <address>
        <city>Linköping</city>
        <zip>SE-58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lars Falk, MD PhD</last_name>
      <email>lars.falk@lio.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>December 12, 2014</last_update_submitted>
  <last_update_submitted_qc>December 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ostergotland County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Lars Falk</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Mycoplasma genitalium</keyword>
  <keyword>Chlamydia trachomatis</keyword>
  <keyword>Treatment</keyword>
  <keyword>Antibiotic resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlamydia Infections</mesh_term>
    <mesh_term>Pleuropneumonia</mesh_term>
    <mesh_term>Mycoplasma Infections</mesh_term>
    <mesh_term>Urethritis</mesh_term>
    <mesh_term>Uterine Cervicitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Doxycycline</mesh_term>
    <mesh_term>Lymecycline</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01661985
org study id: Ostergotland CC
nct id: NCT01661985
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this on-going study is to study the number of days after antibiotic treatment
      has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia
      trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative
      test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained
      vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to
      detect macrolide resistant Mg-strains and study whether there are any emerging macrolide
      resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the
      participating subjects are adherent to the study protocol meaning 12 samples taken during a
      period of four weeks.
Mycoplasma genitalium (Mg), detected in 1980, causes a urogenital infection through sexual
      transmission. In contrast to Chlamydia trachomatis antibiotic resistance is common against
      tetracyclines and is emerging against macrolides such as azithromycin. Both antibiotics are
      recommended as the first line treatment of chlamydia infection. Recent published data,
      however, indicate that 1g azithromycin stat may be only bacteriostatic when treating
      chlamydia.

      The consensus to date is that there should always be a test of cure in pregnant women having
      been treated for chlamydia and in all individuals treated for Mg.

      There are no studies published, to our knowledge, where the time to eradication after
      antibiotic treatment commenced in Mg infection has been evaluated. The first line treatment
      of a confirmed Mg infection is azithromycin 1.5 g given during a period of 5 days. If
      macrolide resistance is plausible or confirmed moxifloxacin 400mg for 7 to 10 days is
      recommended.

      Individuals with symptomatic urethritis or cervicitis and/or being sexual partners to
      individuals being treated for a suspect or confirmed Mg or CT infection were eligible. The
      study subjects were patients attending either of the STD-clinics in Norrköping or Västervik,
      Sweden. All samples were sent to Statens Serum Institut(SSI), Mycoplasma department (Jorgen
      Skov Jensen) for analysis.

      Patients accepting enrolment with a confirmed or highly suspected Mg were receiving
      azithromycin 500 mg the first day and 250mg the following four days.

      Patients where macrolide resistant Mg-strain infection was highly suspected received
      moxifloxacin 400 mg once daily for seven days.

      Those subjects intended to treatment but with a lower degree of suspicion of Mg infection
      were randomized to either a treatment with doxycycline 200 mg the first day and 100 mg once
      daily the following nine days (the custom and recommendation in Sweden for treatment of
      chlamydia and non-specific urethritis or cervicitis) OR a treatment with azithromycin 1g as a
      single dose.

      All participants were given test kits for 12 samples, which were to be sampled three times
      weekly (every second day) during four weeks starting the day after the first day of
      treatment. They were instructed not to have any sexual intercourse during the first week and
      with condom afterwards during the study period. The samples were to be sent once weekly
      (three samples)to SSI.The date of sampling was to be noted on the label of the tube and the
      attaching paper to SSI, where also any symptoms were to be noted. The results of the tests
      were sent to the STD-clinic who informed the patient.

      The study started in February 2010 and inclusion of patients have ended for those subjects
      with a verified M genitalium infection (February 2014), whereas patients with a verified or
      suspected chlamydia infection still are enrolled and randomised to azithromycin 1 g or
      doxycycline. A manuscript will soon be submitted concerning those subjects being treated for
      a M genitalium infection.

      To date 190 patients have been enrolled and also fulfilled the study protocol with sampling
      of specimens.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time from treatment starts to date of first negative test result is achieved up to 30 days.
time frame: From first day of treatment to date of first negative test up to 30 days per subject
description: Three arms. A randomisation (concealed envelopes) to either treatment with azithromycin 1g as a single dose or doxycycline for nine days (200 mg first day and 100 mg following nine (during summer time lymecycline 300mg twice daily for ten days). One un-randomized arm: Treatment with azithromycin 500 mg the first day and 250mg following four days or when indicated moxifloxacin 400 mg once daily for seven days.
measure: Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin
time frame: One month after treatment has started
description: Quantitive pcr of chlamydia and Mg is used. All Mg strains are tested for mutant genes.
measure: Number or rate of patients adherent regarding sampling according to the protocol
time frame: One month after starting sampling
description: To describe whether the subjects are adherent to the study protocol according to doing the sampling and sending the samples correctly.
arm group label: Drug: Azithromycin 1g
arm group type: Active Comparator
description: Azithromycin 1 g,single dose (per os)
arm group label: Drug: Doxycycline/lymecycline 9/10days
arm group type: Active Comparator
description: Tetracycline either as Doxycycline or during June and July lymecycline (due to lower risk of photo-sensitivity) given for treatment in 9(10)days (per os).
arm group label: Azithromycin 1.5 g
arm group type: Active Comparator
description: Patients not randomized but receiving the first line treatment when a confirmed Mg infection
intervention type: Drug
intervention name: Azithromycin
description: In the randomized arm giver orally 1 g as a single dose. In the non-randomized arm given for 5 days 250mg 2x1 first day and 1x1 following four days.
arm group label: Azithromycin 1.5 g
arm group label: Drug: Azithromycin 1g
other name: Zitromax
other name: Azitromax
intervention type: Drug
intervention name: Doxycycline
description: Doxycycline tablets 100 mg 2x1 the first day and 100 mg daily for following eight days (following the Swedish tradition and experience since the 1970s of treating chlamydia)
arm group label: Drug: Doxycycline/lymecycline 9/10days
other name: Doxyferm
intervention type: Drug
intervention name: lymecycline
description: Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
arm group label: Drug: Doxycycline/lymecycline 9/10days
other name: Tetralysal 300mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Falk, MD PhD
role: Principal Investigator
affiliation: Dept of Derm&Venereology Linköping University hospital
last name: Lars Falk, MD PhD
phone: +46 10 103 8507
email: lars.falk@lio.se
last name: Jorgen S Jensen, MD DrMedSci
email: jsj@ssi.dk
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Ostergotland County Council, Sweden
investigator full name: Lars Falk
investigator title: MD PhD
mesh term: Chlamydia Infections
mesh term: Pleuropneumonia
mesh term: Mycoplasma Infections
mesh term: Urethritis
mesh term: Uterine Cervicitis
mesh term: Azithromycin
mesh term: Doxycycline
mesh term: Lymecycline