Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection: Double Blind Randomised Clinical Trial (RCT) to Study the Efficacy of Different Co-administration and Sequential Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- complete clearance of mf in 80% of the infected
研究概览
简要总结
Diethylcarbamazine (DEC) essentially a micro-filaricidal drug is given for 12 days as standard treatment for the clearance of W. bancrofti infection. It takes about one year for the individuals to completely clear the microfilaria from the blood. It takes another two to four years to clear the antigen. The aim of the present study is to shorten the time taken for clearing the Mf and antigen from the blood either by co-administration or sequential administration of a macrofilaricidal drug, Albendazole or doxycycline. This study is a randomized, double blind, controlled clinical trial to study the efficacy of these drug combinations in complete clearance the Mf and antigen from the blood in shorter span of 180 days and 365 days respectively.
详细描述
Purpose:
Lymphatic dwelling parasite W. bancrofti is the most common cause of secondary lymphoedema. Till today, there is no effective treatment protocol for the complete clearance of W. bancrofti infection, in a short duration of time.
Methods:
The investigators conducted a double blind RCT under field conditions recruiting 146 asymptomatic W. bancrofti infected individuals. Participants were randomly assigned one of the four regimens for 12 days, DEC 300 mg + Doxycycline 100 mg co-administration or DEC 300 mg + Albendazole 400 mg co-administration or DEC 300 mg + Albendazole 400 mg sequential administration or control regimen DEC 300 mg. Participants were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residing in or around Pondicherry and adjoining Tamilnadu areas
- •Night blood microfilaria counts > 10 mf/ml by membrane filtration
- •No history of treatment for filarial infection for the last two years at least
- •Willing for home visits by the staff of the center
- •Willing to give written informed consent
排除标准
- •Body weight less than 30 kg
- •Hepatic or renal disease as evidenced by clinical or biochemical abnormalities. - concurrent illness like hypertension, diabetes mellitus, cardiac conditions and epilepsy requiring chronic medication
- •Psychiatric illness
- •Patients under tetracycline or doxycycline therapy
- •History of de-worming by albendazole or other anti-helminthic during last one year
- •Pregnancy or lactation
研究组 & 干预措施
DEC + ALB sequential
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially
干预措施: Diethylcarbamazine (Drug)
DEC + ALB sequential
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially
干预措施: Albendazole (Drug)
DEC + ALB co-admin
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days
干预措施: Diethylcarbamazine (Drug)
DEC + ALB co-admin
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days
干预措施: Albendazole (Drug)
DEC + DOXY co-admin
Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days
干预措施: Diethylcarbamazine (Drug)
DEC + DOXY co-admin
Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days
干预措施: Doxycycline (Drug)
Diethylcarbamazine (DEC)
Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days
干预措施: Diethylcarbamazine (Drug)
结局指标
主要结局
complete clearance of mf in 80% of the infected
时间窗: At 13th week (91 days) post therapy
次要结局
- Complete clearance Mf and complete clearance of antigen from the infected(26 and 52 weeks post therapy)
研究者
Lourduraj John De Britto
Scientist-E (Medical)
Indian Council of Medical Research