Wolbachia endobacteria in filarial infections - exploring their usefulness as targets for novel chemotherapies that are anti-filarial and improve lymphoedema: a randomised double blind placebo-controlled trial

Volkswagen Foundation (VolkswagenStiftung) (Germany)0 个研究点目标入组 150 人开始时间: 2009年2月13日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Men and women aged between 18 - 60 years
•2. Resident in the village for five years or more
•3. Clinical stage of lymphoedema (1 - 5) of at least one extremity
•4. Good general health without any clinical condition requiring long-term medication
•5. Minimum body weight 40 kg

•1. Pregnancy (if not obvious all women are tested by dipstick chemistry: beta-human chorionic gonadotrophin [BhCG])
•2. Currently breast-feeding
•3. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatological, or renal disease by history, physical examination, and/or laboratory tests
•4. Behavioural, cognitive or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study protocol
•5. Laboratory evidence of liver disease (aspartate aminotransferase [AST], alanine aminotransferase [ALT] and/or gamma-glutamyl transferase [gGT] greater than 1.25 times the upper limit of normal of the testing laboratory)
•6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal of the testing laboratory)
•7. Other condition that, in the opinion of the investigator, would jeopardise the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol
•8. Volunteer has abused alcohol or illicit drugs during the past 6 months by history
•9. History of severe allergic reaction or anaphylaxis
•10. Intolerance to doxycycline or amoxicillin

发起方

Volkswagen Foundation (VolkswagenStiftung) (Germany)