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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327469
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : April 1, 2011
VLIR-UOS Institutional University Cooperation
Information provided by:
University Ghent

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).

Condition or disease Intervention/treatment Phase
Infection by Trichuris Trichiura Drug: Albendazole, 2 x 400mg Drug: Albendazole 400mg Drug: Mebendazole 500mg Drug: Mebendazole 2 x 500mg Drug: Pyrantel-oxantel + mebendazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327469

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Jimma University
Jimma, Ethiopia
Sponsors and Collaborators
University Ghent
VLIR-UOS Institutional University Cooperation
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Principal Investigator: Jozef Vercruysse, PhD University Ghent

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jozef Vercruysse, University Ghent Identifier: NCT01327469     History of Changes
Other Study ID Numbers: 2010/517
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Communicable Diseases
Enoplida Infections
Adenophorea Infections
Nematode Infections
Parasitic Diseases
Piperazine citrate
Pyrantel Pamoate
DMP 777
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents
Enzyme Inhibitors
Neuromuscular Depolarizing Agents