Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced
NCT ID: NCT01661985
Last Updated: 2014-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2010-02-28
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug: Azithromycin 1g
Azithromycin 1 g,single dose (per os)
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.
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).
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)
lymecycline
Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
Azithromycin 1.5 g
Patients not randomized but receiving the first line treatment when a confirmed Mg infection
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.
Interventions
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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.
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)
lymecycline
Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Statens Serum Institut
OTHER
Ostergotland County Council, Sweden
OTHER
Responsible Party
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Lars Falk
MD PhD
Principal Investigators
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Lars Falk, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Derm&Venereology Linköping University hospital
Locations
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R&D dept of Local Health Care, Östergötland county council
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Lars Falk, MD PhD
Role: primary
References
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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.
Other Identifiers
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Ostergotland CC
Identifier Type: -
Identifier Source: org_study_id