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Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

Primary Purpose

Filarial; Infestation

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Diethylcarbamazine
Albendazole
Doxycycline
Sponsored by
Indian Council of Medical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Filarial; Infestation focused on measuring Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vector Control Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

DEC + ALB sequential

DEC + ALB co-admin

DEC + DOXY co-admin

Diethylcarbamazine (DEC)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

complete clearance of mf in 80% of the infected

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2013
Last Updated
December 6, 2013
Sponsor
Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT02005653
Brief Title
Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Filarial; Infestation
Keywords
Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEC + ALB sequential
Arm Type
Experimental
Arm Description
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially
Arm Title
DEC + ALB co-admin
Arm Type
Experimental
Arm Description
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days
Arm Title
DEC + DOXY co-admin
Arm Type
Experimental
Arm Description
Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days
Arm Title
Diethylcarbamazine (DEC)
Arm Type
Active Comparator
Arm Description
Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days
Intervention Type
Drug
Intervention Name(s)
Diethylcarbamazine
Other Intervention Name(s)
DEC
Intervention Description
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Intervention Type
Drug
Intervention Name(s)
Albendazole
Other Intervention Name(s)
Alb
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Doxy
Intervention Description
Experimental
Primary Outcome Measure Information:
Title
complete clearance of mf in 80% of the infected
Time Frame
At 13th week (91 days) post therapy
Secondary Outcome Measure Information:
Title
Complete clearance Mf and complete clearance of antigen from the infected
Description
a)Complete clearance of Mf by 26 weeks (180 days) post therapy. b) Complete clearance of antigen by 52 weeks (365days) post therapy
Time Frame
26 and 52 weeks post therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourduraj J De Britto, M.D
Organizational Affiliation
Vector Control Research Centre, Indian Council of Medical Research, Pondicherry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vector Control Research Centre
City
Pondicherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26691247
Citation
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.
Results Reference
derived

Learn more about this trial

Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

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