A Phase 4 interventional study of Albendazole, 2 x 400mg and Albendazole 400mg in Infection by Trichuris Trichiura, sponsored by University Ghent. Completed at 1 site in Ethiopia. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-01.
Sponsored by University Ghent · Phase 4, Interventional, and Treatment
The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH and more than one billion individuals are thought to be infected, of which 450 million have significant morbidity attributable from their infection, school-aged children in particular. In this population infections cause stunting of the linear growth, anemia, reduce the cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are highly prevalent, affecting more than 60% of the children (data not published).
Current efforts to control STH infections involve periodic mass drug anthelmintic treatment of infected children in endemic areas and are likely to intensify as more attention is addressed to the importance of these neglected diseases. Monitoring drug efficacy in these control programs has become indispensable in order to detect the emergence of resistance and/or identify confounding factors affecting the drug efficacy. Recently a study has evaluated a single dose albendazole (ALB) in school age children across 7 countries, including Ethiopia, revealing that this regime is highly efficacious for the treatment of A. lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate. Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose 10mg/kg), of which the latter holds promise as it can also be administrated to children between 6 months and 2 years. The main objective of the present study, therefore, is to assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x 500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 2,250 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 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.
albendazole, 1 x 400mg
Drug: Albendazole 400mg
albendazole, 2 x 400mg
Drug: Albendazole, 2 x 400mg
mebendazole, 1 x 500mg
Drug: Mebendazole 500mg
mebendazole, 2x 500mg
Drug: Mebendazole 2 x 500mg
pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)
Drug: Pyrantel-oxantel + mebendazole
Albendazole 2 x 400mg
Albendazole 400mg
Mebendazole 500mg
Mebendazole 2 x 500mg
Pyrantel-oxantel + mebendazole
Efficacy against T. trichiura of various treatment regimes
The evaluation of the efficacy against T. trichiura of various treatment regimes. To this end, subjects infected with T. trichura (based on McMaster), will be randomly assigned to one of the five proposed treatment regimes. Two weeks after the treatment, faecal egg counts will be performed and the reduction in faecal egg counts will be evaluated
Time frame: After two weeks treatment
The record gives a start of Dec 2010, a primary completion of Feb 2011 and a completion of Mar 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Albendazole · Mebendazole