ISRCTN14042737已完成2 期
Doxycycline 200 mg/d vs 100 mg/d for 6 weeks to improve filarial lymphedema: a multi-national, double-blind, randomized, placebo-controlled trial
Kumasi Centre for Collaborative Research (KCCR)0 个研究点目标入组 420 人开始时间: 2017年7月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
研究概览
简要总结
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32228663 protocol (added 02/04/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Lymphedema of at least one leg grade 1-6 measured on a 7-point scale [3]
- •2. Age = 14 years and = 65 years
- •3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
- •4. Negative pregnancy test
- •5. Body weight = 40 kg
- •6. Resident in LF endemic area for = 2 years
- •7. Able and willing to give informed consent/ to provide assent to participate in the trial
- •8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
排除标准
- •1. No lymphedema or lymphedema stage 7
- •2. Age < 14 years or > 65 years
- •3. Body weight < 40 kg
- •4. Pregnant or breastfeeding women
- •5. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
- •6. Clinical or biologic evidence of hepatic or renal dysfunction or disease of the central nervous system (CNS)
- •7. Evidence of severe comorbidities except for features of filarial disease
- •8. Alcohol or drug abuse
- •9. History of adverse reactions to doxycycline or other tetracyclines
- •10. Any significant condition (including medical and psychological/ psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study
- •11. History of photosensitivity reactions after taking drugs.
- •12. Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
- •13. Concomitant medication with other antibiotics than doxycycline and not able to discontinue
- •14. Concomitant medication with diuretics or sulfonylurea
- •15. Concomitant medication with coumarin
- •16. Haemoglobin < 8 gm/dL
- •17. Neutrophil count <2000/mm3 - Updated 03/08/2018: Neutrophil count < 1100/mm3
- •18. Platelet count <100 000/mm3
- •19. Creatinine > 2 times upper limit of normal
- •20. AST (GOT) > 2 times upper limit of normal
- •21. ALT (GPT) > 2 times upper limit of normal
- •22. Gamma-GT > 2 times upper limit of normal
- •23. Positive urine pregnancy test
研究者
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