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

NCT ID: NCT01327469

Last Updated: 2011-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-03-31

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).

Conditions

Infection by Trichuris Trichiura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Albendazole 400mg

albendazole, 1 x 400mg

Group Type: EXPERIMENTAL

Albendazole 400mg

Intervention Type: DRUG

Albendazole 400mg

Albendazole 2 x 400mg

albendazole, 2 x 400mg

Group Type: EXPERIMENTAL

Albendazole, 2 x 400mg

Intervention Type: DRUG

Albendazole 2 x 400mg

Mebendazole 500mg

mebendazole, 1 x 500mg

Group Type: EXPERIMENTAL

Mebendazole 500mg

Intervention Type: DRUG

Mebendazole 500mg

Mebendazole 2 x 500mg

mebendazole, 2x 500mg

Group Type: EXPERIMENTAL

Mebendazole 2 x 500mg

Intervention Type: DRUG

Mebendazole 2 x 500mg

Pyrantel-oxantel + mebendazole

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

Group Type: EXPERIMENTAL

Pyrantel-oxantel + mebendazole

Intervention Type: DRUG

Pyrantel-oxantel + mebendazole

Interventions

Albendazole, 2 x 400mg

Albendazole 2 x 400mg

Intervention Type: DRUG

Albendazole 400mg

Albendazole 400mg

Intervention Type: DRUG

Mebendazole 500mg

Mebendazole 500mg

Intervention Type: DRUG

Mebendazole 2 x 500mg

Mebendazole 2 x 500mg

Intervention Type: DRUG

Pyrantel-oxantel + mebendazole

Pyrantel-oxantel + mebendazole

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VLIR-UOS Institutional University Cooperation

UNKNOWN

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

University Ghent

Principal Investigators

Jozef Vercruysse, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Jimma University

Jimma, , Ethiopia

Countries

Ethiopia

References

Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.

Reference Type: DERIVED

PMID: 22189084 (View on PubMed)

Other Identifiers

2010/517

Identifier Type: -

Identifier Source: org_study_id