Infection by Trichuris Trichiura Clinical Trial
Official title:
The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment