The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01327469

Collaborator

VLIR-UOS Institutional University Cooperation (Other)

2,250

Enrollment

Location

Arms

Duration (Months)

760.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Infection by Trichuris Trichiura	Drug: Albendazole, 2 x 400mg Drug: Albendazole 400mg Drug: Mebendazole 500mg Drug: Mebendazole 2 x 500mg Drug: Pyrantel-oxantel + mebendazole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

2250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albendazole 400mg albendazole, 1 x 400mg	Drug: Albendazole 400mg Albendazole 400mg
Experimental: Albendazole 2 x 400mg albendazole, 2 x 400mg	Drug: Albendazole, 2 x 400mg Albendazole 2 x 400mg
Experimental: Mebendazole 500mg mebendazole, 1 x 500mg	Drug: Mebendazole 500mg Mebendazole 500mg
Experimental: Mebendazole 2 x 500mg mebendazole, 2x 500mg	Drug: Mebendazole 2 x 500mg Mebendazole 2 x 500mg
Experimental: Pyrantel-oxantel + mebendazole pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)	Drug: Pyrantel-oxantel + mebendazole Pyrantel-oxantel + mebendazole

Outcome Measures

Primary Outcome Measures

Efficacy against T. trichiura of various treatment regimes [After two weeks treatment]
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