Suspended

Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment

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What is being tested

Azithromycin

+ Doxycycline

+ lymecycline

Drug
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Uterine Cervical Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2010
See protocol details

Summary

Principal SponsorOstergotland County Council, Sweden
Study ContactLars Falk, MD PhDMore contacts
Last updated: December 15, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorOstergotland County Council, Sweden
Study ContactLars Falk, MD PhDMore contacts
Last updated: December 15, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleUrethral DiseasesUrologic DiseasesUterine DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesUterine CervicitisUrethritis

Criteria

1 inclusion criteria required to participate
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)

1 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Azithromycin 1 g,single dose (per os)

Group II

Active Comparator
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).

Group III

Active Comparator
Patients not randomized but receiving the first line treatment when a confirmed Mg infection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

R&D dept of Local Health Care, Östergötland county council

Linköping, SwedenOpen R&D dept of Local Health Care, Östergötland county council in Google Maps
SuspendedOne Study Center