Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Filarial; Infestation

Intervention / Treatment
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* Drug: Diethylcarbamazine
* Drug: Albendazole
* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEC + ALB sequential<br>Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 300 mg tablet as single dose per day for 12 days<br>* Other names: DEC;Drug: Albendazole<br>* Experimental<br>* Other names: Alb;|
| Experimental: DEC + ALB co-admin<br>Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 300 mg tablet as single dose per day for 12 days<br>* Other names: DEC;Drug: Albendazole<br>* Experimental<br>* Other names: Alb;|
| Experimental: DEC + DOXY co-admin<br>Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 300 mg tablet as single dose per day for 12 days<br>* Other names: DEC;Drug: Doxycycline<br>* Experimental<br>* Other names: Doxy;|
| Active Comparator: Diethylcarbamazine (DEC)<br>Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days | Drug: Diethylcarbamazine<br>* Diethylcarbamazine 300 mg tablet as single dose per day for 12 days<br>* Other names: DEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete clearance of mf in 80% of the infected |  | At 13th week (91 days) post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete clearance Mf and complete clearance of antigen from the infected | a)Complete clearance of Mf by 26 weeks (180 days) post therapy. b) Complete clearance of antigen by 52 weeks (365days) post therapy | 26 and 52 weeks post therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline