Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

Indian Council of Medical Research (ICMR)

Status and phase: Completed; Phase 4

Conditions: Filarial; Infestation

Treatments: Drug: Doxycycline; Drug: Diethylcarbamazine; Drug: Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02005653

IM0603-CEC-VCRC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 4 patient groups

DEC + ALB sequential

Experimental group

Description:

Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially

Treatment:

Drug: Albendazole

Drug: Diethylcarbamazine

DEC + ALB co-admin

Experimental group

Description:

Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days

Treatment:

Drug: Albendazole

Drug: Diethylcarbamazine

DEC + DOXY co-admin

Experimental group

Description:

Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days

Treatment:

Drug: Diethylcarbamazine

Drug: Doxycycline

Diethylcarbamazine (DEC)

Active Comparator group

Description:

Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days

Treatment:

Drug: Diethylcarbamazine