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Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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