Alternate Chemotherapy Regimens for the Clearance of W.Bancrofti Infection
NCT ID: NCT02005653
Last Updated: 2013-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
146 participants
INTERVENTIONAL
2009-02-28
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DEC + ALB sequential
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet at 30 days post treatment sequentially
Diethylcarbamazine
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Albendazole
Experimental
DEC + ALB co-admin
Diethylcarbamazine 300 mg tablet and albendazole 400 mg tablet per day given orally as single dose for 12 days
Diethylcarbamazine
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Albendazole
Experimental
DEC + DOXY co-admin
Diethylcarbamazine 300 mg tablet and Doxycycline 100 mg per day given orally as single dose for 12 days
Diethylcarbamazine
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Doxycycline
Experimental
Diethylcarbamazine (DEC)
Diethylcarbamazine 300 mg tablet as single dose orally per day for 12 days
Diethylcarbamazine
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Interventions
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Diethylcarbamazine
Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
Albendazole
Experimental
Doxycycline
Experimental
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Indian Council of Medical Research
OTHER_GOV
Responsible Party
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Lourduraj John De Britto
Scientist-E (Medical)
Principal Investigators
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Lourduraj J De Britto, M.D
Role: PRINCIPAL_INVESTIGATOR
Vector Control Research Centre, Indian Council of Medical Research, Pondicherry
Locations
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Vector Control Research Centre
Puducherry, Puducherry, India
Countries
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References
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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.
Other Identifiers
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IM0603-CEC-VCRC
Identifier Type: -
Identifier Source: org_study_id