Filarial; Infestation
Conditions
Keywords
Lymphatic filariasis, W. bancrofti, DEC, Albendazole, Doxycycline
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.
Interventions
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
DRUGAlbendazole
Experimental
DRUGDoxycycline
Experimental
Sponsors
Indian Council of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete clearance of mf in 80% of the infected | At 13th week (91 days) post therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete clearance Mf and complete clearance of antigen from the infected | 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 |
Countries
India
Outcome results
None listed