Anti-wolbachial therapy with doxycycline to ameliorate filaricele pathology: a randomised, double-blind, placebo-controlled trial

Volkswagen Foundation (VolkswagenStiftung) (Germany)0 个研究点目标入组 66 人开始时间: 2010年7月8日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Men between 18-55 years old
•2. Good general health, without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles
•3. Body weight > 40 kg
•4. Presence of hydrocele stage 2 or 3, detected by ultrasound (as described in Debrah et al., 2007)
•5. Willingness to participate in the study as evidenced by signing of the informed consent document (written or thumb print)
•6. Resident in the endemic area for 5 years or more

•1. Known intolerance to the study drug doxycycline
•2. History of a severe allergic reaction or anaphylaxis
•3. History of alcohol or drug abuse
•4. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, metabolic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses
•5. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche?)
•6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche?)
•7. Laboratory evidence of diabetes (urine dipstick chemistry)
•8.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
•9. Severe asthma or respiratory disease (evidenced by a past emergency room visit or hospitalization)
•10. Participation in other drug trials concurrent with this study
•11. 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

发起方

Volkswagen Foundation (VolkswagenStiftung) (Germany)