Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Time from treatment starts to date of first negative test result is achieved up to 30 days.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Drug: Azithromycin 1g
Azithromycin 1 g,single dose (per os)
干预措施: Azithromycin (Drug)
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).
干预措施: Doxycycline (Drug)
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).
干预措施: lymecycline (Drug)
Azithromycin 1.5 g
Patients not randomized but receiving the first line treatment when a confirmed Mg infection
干预措施: Azithromycin (Drug)
结局指标
主要结局
Time from treatment starts to date of first negative test result is achieved up to 30 days.
时间窗: 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.
次要结局
- Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin(One month after treatment has started)
研究者
Lars Falk
MD PhD
Ostergotland County Council, Sweden