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

March 31, 2011 updated by: University Ghent

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Jimma, Ethiopia
        • Jimma University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After two weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

VLIR-UOS Institutional University Cooperation

Investigators

  • Principal Investigator: Jozef Vercruysse, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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