A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children (WORMCON)

This study has been completed.
Sponsor:
Collaborators:
Ghent University, Faculty of Veterinary Medicine, Dpt of Virology, Parasitology and Immunology, Belgium
World Health Organization
George Washington University
Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia
University of Nottingham
Queensland Institute of Medical Research
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT01087099
First received: March 12, 2010
Last updated: July 30, 2011
Last verified: July 2011
  Purpose

The three major Soil-Transmitted Helminths (STH), Ascaris lumbricoides, Necator americanus/Ancylostoma duodenal and Trichuris trichiura are among the most prevalent parasites worldwide. The objective of this multicentre international study is to define the efficacy of a single 400 milligram dose of albendazole (ALB) against these three STHs using a standardised protocol. The trial will be undertaken among school age children in seven countries - Brazil, Cameroon, Cambodia, Ethiopia, India, Tanzania (Zanzibar) and Vietnam - each with a different epidemiologic pattern of infection. A trial of this nature is urgently required because in spite of the wide usage of albendazole over the last 3 decades, there is still no key publication reporting the efficacy of the anthelmintic accurately, and to modern conventional standards, that can act as a central reference for the baseline efficacy. The latter is critically important because albendazole is now being used even more widely, as large scale mass treatment campaigns are being implemented in Africa and elsewhere, with the intention of reducing morbidity in children. Such large scale usage of a drug risks resistance developing, but resistance cannot be detected unless benchmark values for baseline efficacy are widely known.


Condition Intervention Phase
Infections With Soil-Transmitted Helminths (STH)
Drug: Albendazole
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Efficacy of albendazole [ Time Frame: 14 to 30 days after treatment ] [ Designated as safety issue: No ]
    To determine the efficacy of albendazole, and this will be assessed by the reduction in parasite faecal egg counts between the pre- and post-intervention surveys. The latter will be conducted 14-30 days after treatment.


Estimated Enrollment: 1750
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albendazole
Treatment with albendazole
Drug: Albendazole
Treatment with albendazole

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children should be infected with a minimum of 150 eggs/gram of any of the three species of STH (i.e. Ascaris or hookworms or Trichuris).

Exclusion Criteria:

  • Not willing to participate
  • Unable to give samples for follow up
  • Severe intercurrent medical condition
  • Diarrhoea at first sampling
  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: NCT01087099

Locations
Brazil
Instituto René Rachou, Fundação Oswaldo Cruz
Minas Gerais, Brazil
Cambodia
Institut Pasteur in Cambodia, Clinical Pathology Unit
Phnom Penh, Cambodia
Cameroon
Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I
Yaounde, Cameroon
Ethiopia
Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University
Jimma,, Ethiopia
India
Department of Gastrointestinal Sciences, Christian Medical College
Vellore, India
Tanzania
Public Health Laboratory
Zanzibar, Tanzania
Vietnam
National Institute for Malariology, Parasitology and Entomology
Hanoi, Vietnam
Sponsors and Collaborators
University Ghent
Ghent University, Faculty of Veterinary Medicine, Dpt of Virology, Parasitology and Immunology, Belgium
World Health Organization
George Washington University
Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia
University of Nottingham
Queensland Institute of Medical Research
Investigators
Principal Investigator: Jozef Vercruysse 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: NCT01087099     History of Changes
Other Study ID Numbers: 2008/322
Study First Received: March 12, 2010
Last Updated: July 30, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Anthelmintics
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014