Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

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

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.

Study Overview

• Status: Completed
• Conditions: Filarial; Infestation
• Intervention / Treatment: Drug: Diethylcarbamazine; Drug: Albendazole; Drug: Doxycycline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Pondicherry, India, 605006
    • Vector Control Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Indian Council of Medical Research
• Investigators: Principal Investigator: Lourduraj J De Britto, M.D, Vector Control Research Centre, Indian Council of Medical Research, Pondicherry

Publications and helpful links

General Publications

• De Britto RL, Vanamail P, Sankari T, Vijayalakshmi G, Das LK, Pani SP. Enhanced efficacy of sequential administration of Albendazole for the clearance of Wuchereria bancrofti infection: Double blind RCT. Trop Biomed. 2015 Jun;32(2):198-209.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 6, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Doxycycline; Albendazole; Lymphatic filariasis; W. bancrofti; DEC
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Filaricides; Antinematodal Agents; Anthelmintics; Antiplatyhelmintic Agents; Lipoxygenase Inhibitors; Anticestodal Agents; Doxycycline; Albendazole; Diethylcarbamazine
• Other Study ID Numbers: IM0603-CEC-VCRC