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Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661985
Recruitment Status : Unknown
Verified December 2014 by Lars Falk, Ostergotland County Council, Sweden.
Recruitment status was:  Recruiting
First Posted : August 10, 2012
Last Update Posted : December 15, 2014
Statens Serum Institut
Information provided by (Responsible Party):
Lars Falk, Ostergotland County Council, Sweden

Tracking Information
First Submitted Date  ICMJE July 27, 2012
First Posted Date  ICMJE August 10, 2012
Last Update Posted Date December 15, 2014
Study Start Date  ICMJE February 2010
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
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 ]
Quantitive pcr of chlamydia and Mg is used. All Mg strains are tested for mutant genes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2012)
Number or rate of patients adherent regarding sampling according to the protocol [ Time Frame: One month after starting sampling ]
To describe whether the subjects are adherent to the study protocol according to doing the sampling and sending the samples correctly.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced
Official Title  ICMJE Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urethritis
  • Cervicitis
  • Genital Mycoplasma Infection
  • Chlamydia Trachomatis
Intervention  ICMJE
  • Drug: Azithromycin
    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.
    Other Names:
    • Zitromax
    • Azitromax
  • Drug: Doxycycline
    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)
    Other Name: Doxyferm
  • Drug: lymecycline
    Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
    Other Name: Tetralysal 300mg
Study Arms  ICMJE
  • Active Comparator: Drug: Azithromycin 1g
    Azithromycin 1 g,single dose (per os)
    Intervention: Drug: Azithromycin
  • Active Comparator: Drug: Doxycycline/lymecycline 9/10days
    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).
    • Drug: Doxycycline
    • Drug: lymecycline
  • Active Comparator: Azithromycin 1.5 g
    Patients not randomized but receiving the first line treatment when a confirmed Mg infection
    Intervention: Drug: Azithromycin
Publications * Falk L, Enger M, Jensen JS. Time to eradication of Mycoplasma genitalium after antibiotic treatment in men and women. J Antimicrob Chemother. 2015 Nov;70(11):3134-40. doi: 10.1093/jac/dkv246. Epub 2015 Aug 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 7, 2012)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals attending the STD-clinic and being a sexual partner who has received an antibiotic treatment due to a non-specific urethritis/cervicitis or a confirmed Mycoplasma genitalium/Chlamydia trachomatis infection OR Having a confirmed infection described above or a symptomatic urethritis or cervicitis (non-gonorrhoic)

Exclusion Criteria:

  • Allergy against any of the drugs, woman being pregnant or breast feeding, Not speaking or understanding Swedish fluently. Other medication with possible interaction to given treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01661985
Other Study ID Numbers  ICMJE Ostergotland CC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lars Falk, Ostergotland County Council, Sweden
Study Sponsor  ICMJE Ostergotland County Council, Sweden
Collaborators  ICMJE Statens Serum Institut
Investigators  ICMJE
Principal Investigator: Lars Falk, MD PhD Dept of Derm&Venereology Linköping University hospital
PRS Account Ostergotland County Council, Sweden
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP