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

This study has been completed.
Sponsor:
Collaborator:
VLIR-UOS Institutional University Cooperation
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT01327469
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Efficacy against T. trichiura of various treatment regimes [ Time Frame: After two weeks treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 2250
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327469

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

No publications provided by University Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jozef Vercruysse, University Ghent
ClinicalTrials.gov Identifier: NCT01327469     History of Changes
Other Study ID Numbers: 2010/517
Study First Received: March 30, 2011
Last Updated: March 31, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Infection
Communicable Diseases
Trichuriasis
Enoplida Infections
Adenophorea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Mebendazole
Piperazine citrate
Piperazine
Anthelmintics
Pyrantel
Pyrantel Pamoate
Oxantel
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents
Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on September 18, 2014