A Phase 4 interventional study of Diethylcarbamazine and Albendazole in Filarial; Infestation, sponsored by Indian Council of Medical Research. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-09.
Sponsored by Indian Council of Medical Research · Phase 4, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Parasitic Diseases; 8 are open to participants now.
This study's enrollment of 146 is close to the median of 151 across 41 interventional studies indexed under Parasitic Diseases.
Browse Parasitic Diseases studies →Indian Council of Medical Research is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days
Drug: Diethylcarbamazine · Drug: Albendazole
Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days
Drug: Diethylcarbamazine · Drug: Doxycycline
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
Also known as: DEC
Experimental
Also known as: Alb
Experimental
Also known as: Doxy
complete clearance of mf in 80% of the infected
Time frame: At 13th week (91 days) post therapy
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
Time frame: 26 and 52 weeks post therapy
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Albendazole · Doxycycline
Indian Council of Medical Research