ISRCTN68861628已完成未知
Comparison of doxycycline alone vs doxycycline plus rifampicin in their efficacy against onchocerciasis: a randomised double-blind placebo-controlled trial
iverpool School of Tropical Medicine (UK)0 个研究点目标入组 500 人开始时间: 2009年4月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men and women between 18-55 years
- •2. Good general health without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles
- •3. Body weight (BW): 40-70 kg
- •4. Presence of at least 1 palpable onchocercoma
排除标准
- •1. Known intolerance to the study drugs (doxycycline, rifampicin)
- •2. Pregnancy (if not obvious, all women are tested by dipstick chemistry (ß-hCG), the test will be carried out pre-treatment and every 2 weeks during treatment)
- •3. Currently breast-feeding
- •4. History of severe allergic reaction or anaphylaxis
- •5. History of alcohol or drug abuse
- •6. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses
- •7. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-GT greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche)
- •8. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche)
- •9. Laboratory evidence of diabetes (urine dipstick chemistry)
- •10. Behavioural, cognitive or psychiatric disease that, in the opinion of the trial clinician, affects the ability of the participant to understand and comply with the study
- •11. Severe asthma (emergency room visit or hospitalisation)
- •12. Undergone splenectomy
- •13. Participation in other drug trials concurrent with this study
- •14. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol
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