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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01327469
Enrollment
2250
Registered
2011-04-01
Start date
2010-12-31
Completion date
2011-03-31
Last updated
2011-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection by Trichuris Trichiura

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).

Interventions

DRUGAlbendazole, 2 x 400mg

Albendazole 2 x 400mg

Albendazole 400mg

DRUGMebendazole 500mg

Mebendazole 500mg

DRUGMebendazole 2 x 500mg

Mebendazole 2 x 500mg

DRUGPyrantel-oxantel + mebendazole

Pyrantel-oxantel + mebendazole

Sponsors

VLIR-UOS Institutional University Cooperation
CollaboratorUNKNOWN
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy against T. trichiura of various treatment regimesAfter two weeks treatmentThe 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

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026