Clinical trial NCT02005653: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Filarial; Infestation
Keywords: Lymphatic filariasis
W. bancrofti
DEC
Albendazole
Doxycycline
Lead sponsor: Indian Council of Medical Research
Sponsor class: OTHER_GOV
First posted: 2013-12-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: complete clearance of mf in 80% of the infected
timeFrame: At 13th week (91 days) post therapy
Secondary outcomes:
measure: Complete clearance Mf and complete clearance of antigen from the infected
timeFrame: 26 and 52 weeks post therapy
Other outcomes:
Locations:
city: Pondicherry
country: India
facility: Vector Control Research Centre
Study officials:
affiliation: Vector Control Research Centre, Indian Council of Medical Research, Pondicherry
name: Lourduraj J De Britto, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.