Efficacy Albendazole and Levamisole Against STH on Unguja
NCT ID: NCT00659997
Last Updated: 2008-04-17
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
20 participants
INTERVENTIONAL
2006-06-30
2007-09-30
Brief Summary
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The prevalence of Ascaris lumbricoides was found to have remained relatively high despite community-wide treatment with the mass administration of Albendazole (a WHO recommended de-wormer) in coordination with community vitamin A supplementation.
One hypothesis for this is that the children and mothers had Ascaris infections more tolerant to Albendazole that subsequently failed to clear. It is necessary to compare the present drug efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on STH infections such patients a case-control setting to shed light on the putative resistance of local Ascaris/Trichuris to albendazole.
In so doing, this should clarify whether there is resistance developing towards Albendazole and have possible implications for introducing combination therapies of Levamisole and Albendazole for first line de-worming mothers and their children in the future.
Detailed Description
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Stool specimens were transported to the Helmtin Control Laboratory Unguja laboratory for visual inspection of stool consistency and presence of blood, after which a single Kato-Katz thick smear (41.7mg) was prepared. Eggs of all STH species were counted by inspection at 100x microscopy and expressed as a tally of eggs per gram (EPG). To ensure consistency of egg counts, slides were read by the same two technicians for each study village.
10 Mother and child pairs found positive for Ascaris and/or Trichuris were randomised, by coin tossing, to receive either a single tablet of ALB (400mg) or an appropriate dose of LEV (2.5 mg/kg). A parasitological follow-up took place 18 days after treatment where a requested stool sample was analyzed by a single Kato-Katz thick smear for assessment of STH clearance. In accordance with WHO's 'no survey without service' all attendees were given an additional ALB tablet.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
1 Individuals treated with Albendazole
Albendazole
Single oral dose of 400mg
2
Individuals treated with Levamisole
Levamisole
Single oral dose of 2.5mg/kg
Interventions
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Albendazole
Single oral dose of 400mg
Levamisole
Single oral dose of 2.5mg/kg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
45 Years
FEMALE
No
Sponsors
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Ministry of Health, Tanzania
OTHER_GOV
University of London
OTHER
Natural History Museum, United Kingdom
OTHER_GOV
Responsible Party
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Natural History Museum
Locations
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Helminth Control Laboratory Unguja
Stone Town, , Tanzania
Countries
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References
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Stothard JR, Imison E, French MD, Sousa-Figueiredo JC, Khamis IS, Rollinson D. Soil-transmitted helminthiasis among mothers and their pre-school children on Unguja Island, Zanzibar with emphasis upon ascariasis. Parasitology. 2008 Oct;135(12):1447-55. doi: 10.1017/S0031182008004836. Epub 2008 Sep 8.
Other Identifiers
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NHMDEWORMING
Identifier Type: -
Identifier Source: org_study_id