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Clinical Trials/NCT01327469
NCT01327469
Completed
Phase 4

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

University Ghent1 site in 1 country2,250 target enrollmentStarted: December 2010Last updated:

Overview

Phase
Phase 4
Status
Completed
Enrollment
2,250
Locations
1
Primary Endpoint
Efficacy against T. trichiura of various treatment regimes

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • all school age children who are eligible to participate in the study

Exclusion Criteria

  • Not willing to participate (no informed consent)
  • Unable to give samples for follow up
  • Severe intercurrent medical condition
  • Diarrhea at first sampling
  • Study subjects who had treatment for STH in the last 3 months

Arms & Interventions

Albendazole 400mg

Experimental

albendazole, 1 x 400mg

Intervention: Albendazole 400mg (Drug)

Albendazole 2 x 400mg

Experimental

albendazole, 2 x 400mg

Intervention: Albendazole, 2 x 400mg (Drug)

Mebendazole 500mg

Experimental

mebendazole, 1 x 500mg

Intervention: Mebendazole 500mg (Drug)

Mebendazole 2 x 500mg

Experimental

mebendazole, 2x 500mg

Intervention: Mebendazole 2 x 500mg (Drug)

Pyrantel-oxantel + mebendazole

Experimental

pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)

Intervention: Pyrantel-oxantel + mebendazole (Drug)

Outcomes

Primary Outcomes

Efficacy against T. trichiura of various treatment regimes

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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