Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

NCT02005653 | Completed Phase 4 DMC

• 1 other identifier: IM0603-CEC-VCRC
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Filarial; Infestation

Keywords

Lymphatic filariasis; W. bancrofti; DEC; Albendazole; Doxycycline

Outcome Measures

Primary Outcomes (1)

• complete clearance of mf in 80% of the infected

  At 13th week (91 days) post therapy

Secondary Outcomes (1)

• Complete clearance Mf and complete clearance of antigen from the infected

  26 and 52 weeks post therapy

Study Arms (4)

DEC + ALB sequential

EXPERIMENTAL

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

Drug: Diethylcarbamazine; Drug: Albendazole

DEC + ALB co-admin

EXPERIMENTAL

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

Drug: Diethylcarbamazine; Drug: Albendazole

DEC + DOXY co-admin

EXPERIMENTAL

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

Drug: Diethylcarbamazine; Drug: Doxycycline

Diethylcarbamazine (DEC)

ACTIVE COMPARATOR

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

Drug: Diethylcarbamazine

Interventions

Diethylcarbamazine DRUG

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

Also known as: DEC

DEC + ALB co-admin; DEC + ALB sequential; DEC + DOXY co-admin; Diethylcarbamazine (DEC)

Albendazole DRUG

Experimental

Also known as: Alb

DEC + ALB co-admin; DEC + ALB sequential

Doxycycline DRUG

Experimental

Also known as: Doxy

DEC + DOXY co-admin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indian Council of Medical Research: lead

Study Sites (1)

Vector Control Research Centre

Puducherry, Puducherry, 605006, India

Location

Related Publications (1)

• 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.

  PMID: 26691247 DERIVED

MeSH Terms

Conditions

Parasitic Diseases; Elephantiasis, Filarial

Interventions

Diethylcarbamazine; Albendazole; Albumins; Doxycycline

Condition Hierarchy (Ancestors)

Infections; Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Proteins; Amino Acids, Peptides, and Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Lourduraj J De Britto, M.D

  Vector Control Research Centre, Indian Council of Medical Research, Pondicherry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist-E (Medical)

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: August 1, 2013
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

IN (1)