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NCT Number: NCT02005653

Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vector Control Research Centre

Puducherry, 605006, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diethylcarbamazine

Drug

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

Other names: DEC

Albendazole

Drug

Experimental

Other names: Alb

Doxycycline

Drug

Experimental

Other names: Doxy

Primary outcomes

  1. complete clearance of mf in 80% of the infected

    Time frame: At 13th week (91 days) post therapy

Secondary outcomes

  1. Complete clearance Mf and complete clearance of antigen from the infected

    Time frame: 26 and 52 weeks post therapy

    a)Complete clearance of Mf by 26 weeks (180 days) post therapy. b) Complete clearance of antigen by 52 weeks (365days) post therapy

Sponsors and collaborators

Lead sponsor

Indian Council of Medical Research

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Dec 9, 2013
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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