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

Primary Purpose

Infection by Trichuris Trichiura

Status
Completed
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
Albendazole, 2 x 400mg
Albendazole 400mg
Mebendazole 500mg
Mebendazole 2 x 500mg
Pyrantel-oxantel + mebendazole
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection by Trichuris Trichiura

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jimma University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Albendazole 400mg

Albendazole 2 x 400mg

Mebendazole 500mg

Mebendazole 2 x 500mg

Pyrantel-oxantel + mebendazole

Arm Description

albendazole, 1 x 400mg

albendazole, 2 x 400mg

mebendazole, 1 x 500mg

mebendazole, 2x 500mg

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

Outcomes

Primary Outcome Measures

Efficacy against T. trichiura of various treatment regimes
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 Outcome Measures

Full Information

First Posted
March 30, 2011
Last Updated
March 31, 2011
Sponsor
University Ghent
Collaborators
VLIR-UOS Institutional University Cooperation
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1. Study Identification

Unique Protocol Identification Number
NCT01327469
Brief Title
The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia
Official Title
The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Ghent
Collaborators
VLIR-UOS Institutional University Cooperation

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection by Trichuris Trichiura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albendazole 400mg
Arm Type
Experimental
Arm Description
albendazole, 1 x 400mg
Arm Title
Albendazole 2 x 400mg
Arm Type
Experimental
Arm Description
albendazole, 2 x 400mg
Arm Title
Mebendazole 500mg
Arm Type
Experimental
Arm Description
mebendazole, 1 x 500mg
Arm Title
Mebendazole 2 x 500mg
Arm Type
Experimental
Arm Description
mebendazole, 2x 500mg
Arm Title
Pyrantel-oxantel + mebendazole
Arm Type
Experimental
Arm Description
pyrantel-oxantel (10mg/kg)+ mebendazole (500mg)
Intervention Type
Drug
Intervention Name(s)
Albendazole, 2 x 400mg
Intervention Description
Albendazole 2 x 400mg
Intervention Type
Drug
Intervention Name(s)
Albendazole 400mg
Intervention Description
Albendazole 400mg
Intervention Type
Drug
Intervention Name(s)
Mebendazole 500mg
Intervention Description
Mebendazole 500mg
Intervention Type
Drug
Intervention Name(s)
Mebendazole 2 x 500mg
Intervention Description
Mebendazole 2 x 500mg
Intervention Type
Drug
Intervention Name(s)
Pyrantel-oxantel + mebendazole
Intervention Description
Pyrantel-oxantel + mebendazole
Primary Outcome Measure Information:
Title
Efficacy against T. trichiura of various treatment regimes
Description
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
Time Frame
After two weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozef Vercruysse, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jimma University
City
Jimma
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22189084
Citation
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.
Results Reference
derived

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

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