跳至主要内容
临床试验/ISRCTN15320064
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

Kumasi Centre for Collaborative Research in Tropical Medicine0 个研究点目标入组 480 人开始时间: 2022年3月29日最近更新:

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

相似试验