Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005653
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Lourduraj John De Britto, Indian Council of Medical Research

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.

Condition or disease Intervention/treatment Phase
Filarial; Infestation Drug: Diethylcarbamazine Drug: Albendazole Drug: Doxycycline Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : August 2013


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 Name: DEC

Drug: Albendazole
Experimental
Other Name: 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 Name: DEC

Drug: Albendazole
Experimental
Other Name: 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 Name: DEC

Drug: Doxycycline
Experimental
Other Name: 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 Name: DEC




Primary Outcome Measures :
  1. complete clearance of mf in 80% of the infected [ Time Frame: At 13th week (91 days) post therapy ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005653


Locations
Layout table for location information
India
Vector Control Research Centre
Pondicherry, India, 605006
Sponsors and Collaborators
Indian Council of Medical Research
Investigators
Layout table for investigator information
Principal Investigator: Lourduraj J De Britto, M.D Vector Control Research Centre, Indian Council of Medical Research, Pondicherry

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lourduraj John De Britto, Scientist-E (Medical), Indian Council of Medical Research
ClinicalTrials.gov Identifier: NCT02005653     History of Changes
Other Study ID Numbers: IM0603-CEC-VCRC
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Lourduraj John De Britto, Indian Council of Medical Research:
Lymphatic filariasis
W. bancrofti
DEC
Albendazole
Doxycycline

Additional relevant MeSH terms:
Layout table for MeSH terms
Parasitic Diseases
Doxycycline
Albendazole
Diethylcarbamazine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Filaricides
Antinematodal Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors