ISRCTN15216778已完成不适用
Comparison of doxycycline alone versus doxycycline plus rifampicin in their efficacy against lymphatic filariasis: a randomised, double-blind, placebo-controlled trial
iverpool School of Tropical Medicine (UK)0 个研究点目标入组 299 人开始时间: 2009年4月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
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
- Male
入选标准
- •Current inclusion criteria as of 08/11/2012 (protocol change approved by the DMEC of this trial on 02/03/2011):
- •1. Men aged between 18 - 50 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): =40kg
- •4. Presence of at least one scrotal worm nest detected by ultrasonography
- •Previous inclusion criteria until 08/11/2012:
- •3. Body weight (BW): 40 - 70 kg
排除标准
- •1. Known intolerance to the study drugs (doxycycline, rifampicin), or to ivermectin and/or albendazole
- •2. History of severe allergic reaction or anaphylaxis
- •3. History of alcohol or drug abuse
- •4. Anti-filarial therapy within the last 10 months
- •5. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analysis
- •6. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche®)
- •7. 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®)
- •8. Laboratory evidence of diabetes (urine dipstick chemistry)
- •9. 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
- •10. Severe asthma or respiratory disease (emergency room visit or hospitalisation)
- •11. Undergone splenectomy
- •12. Participation in other drug trials concurrent with this study
- •13. 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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