PACTR201708002420261尚未招募未知
Doxycycline 200mg/d vs. 100mg/d for 6 weeks to improve filarial lymphedema - a multinational, double-blind, randomized, placebo-controlled trial
Kumasi Centre for Collaborative Research0 个研究点目标入组 420 人开始时间: 2017年7月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
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
- 年龄范围
- 14 Year(s) 至 65 Year(s)（—）
- 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 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
- •Concomitant medication with coumarin
- •Laboratory values which will lead to exusion
- •1. Haemoglobin < 8 gm/dL
- •2. Neutrophil count <2 000/mm3
- •3. Platelet count <100 000/mm3
- •4. Creatinine > 2 times upper limit of normal
- •5. AST (GOT) > 2 times upper limit of normal
- •6. ALT (GPT) > 2 times upper limit of normal
- •7. y-GT > 2 times upper limit of normal
- •8. Positive urine pregnancy test
研究者
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