Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
研究概览
简要总结
The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.
Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).
Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.
Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).
详细描述
OBJECTIVES
The primary objective of this study is to determine the relative effectiveness of azithromycin and doxycycline in eradicating Mycoplasma genitalium and Ureaplasmas among men with nongonococcal urethritis (NGU).
Secondary objectives of this study are to:
- determine the sensitivity of persisting organisms to azithromycin and doxycycline by performing minimum inhibitory concentration (MIC) testing
- determine the relationship between persistence/recurrence of clinical signs and persistent/recurrent detection of M. genitalium and Ureaplasmas among men with NGU treated with azithromycin or doxycycline, measured by follow-up clinical exams and repeated assays performed on specimens collected at follow-up study visits
STUDY DESCRIPTION
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Has a visible urethral discharge or greater than or equal to 5 polymorphonuclear leukocytes (PMNs) per high power field on a Gram-stained slide of a urethral swab sample
- •Possesses and is willing to disclose valid contact information for follow-up
- •English-speaking
- •Gives informed consent
- •Exhibits understanding of study procedures
- •Exhibits ability to comply with study procedures for the entire length of the study
排除标准
- •Has previously participated in this study
- •Has taken antibiotics within the prior month
- •Has known allergies to tetracyclines or azithromycin
- •Is being treated with any of the following: warfarin, ergot derivatives, pimozide (Orap), propafenone (Rytmonorm, Rythmol), disopyramide (Norpace, Rythmodan), rifampin, digoxin, isotretinoin, or methotrexate
- •Has received a kidney, heart, or lung transplant.
- •Is undertaking concomitant systemic steroid therapy
研究组 & 干预措施
Active azithromycin+placebo doxycycline
Active azithromycin (1g) and placebo doxycycline
干预措施: Azithromycin (Drug)
Active doxycycline+placebo azithromycin
Active doxycycline and placebo azithromycin
干预措施: Doxycycline (Drug)
结局指标
主要结局
mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit
时间窗: approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)
Microbiologic cure of M. genitalium at first follow-up visit (defined as a negative in-house PCR test performed on urine)
mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit
时间窗: 3 weeks (allowable window 2-5)
Microbiologic cure, defined as negative PCR for U. urealyticum (if cultured), or negative culture at first follow-up visit
次要结局
- Minimum Inhibitory Concentrations (MIC) of U. Ureaplasma Biovar 2(baseline)
- Minimum Inhibitory Concentrations (MIC) of U. Parvum(baseline)
- Clinical Cure Among Case Subjects Who Were Positive for Ureaplasmas at the Initial Study Visit(approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit))
- Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Azithromycin(baseline)
- Clinical Cure Among Case Subjects Who Were Positive for M. Genitalium at the Initial Study Visit(approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit))
- Minimum Inhibitory Concentrations (MIC) of M. Genitalium for Doxycycline(baseline)
研究者
Lisa Manhart
Study Principal Investigator
University of Washington