ISRCTN15320064进行中(未招募)3 期
Comparing the effectiveness of test and treat approaches with doxycycline or the triple-drug therapy with ivermectin/diethylcarbamazine/albendazole vs ivermectin/albendazole for targeted elimination of lymphatic filariasis in a Phase III clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 入组人数
- 480
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. Age =5 years
- •2. LF-infected person (CFA positive)
- •3. Able and willing to give informed consent
排除标准
- •Specific exclusion criteria for DOX 100 participants:
- •1. Age <14 years or >70 years
- •2. Body weight <40 kg
- •3. Pregnant or breastfeeding women
- •4. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
- •5. Known hepatic or renal dysfunction or disease of the central nervous system (CNS)
- •6. History of alcohol or drug abuse
- •7. History of serious adverse reactions to doxycycline or other tetracyclines
- •8. History of photosensitivity reactions after taking drugs.
- •9. Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
- •10. Concomitant medication with other antibiotics than doxycycline and not able to discontinue
- •11. Concomitant medication with diuretics, sulfonylurea or coumarin (coumadin)
- •12. Any significant condition other than filariasis (including medical and psychological/psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study
- •Laboratory values that will lead to exclusion:
- •1. Positive urine pregnancy test
- •Specific exclusion criteria for IDA participants:
- •1. Age <18 years and >70 years
- •2. Pregnant or breastfeeding women
- •3. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
- •4. Known hepatic or renal dysfunction or disease of the central nervous system (CNS)
- •5. History of alcohol or drug abuse
- •6. History of serious adverse reactions to ivermectin, diethylcarbamazine or albendazole
- •7. Any significant condition other than filariasis (including medical and psychological/psychiatric disorder) that in the opinion of the study investigator might interfere with the conduct of the study
- •Laboratory values that will lead to exclusion:
- •1. Positive urine pregnancy test
- •2. Detection of Onchocerca volvulus MF in skin snips after ivermectin but prior to IDA treatment
- •No exclusion criteria apply to participants from the control group (MDA only)
研究者
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