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

March 12, 2010
July 30, 2011
January 2009
December 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01087099 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infections With Soil-Transmitted Helminths (STH)
Drug: Albendazole
Treatment with albendazole
Experimental: Albendazole
Treatment with albendazole
Intervention: Drug: Albendazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1750
March 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Cambodia,   Cameroon,   Ethiopia,   India,   Tanzania,   Vietnam
 
NCT01087099
2008/322
No
Jozef Vercruysse, University Ghent
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
Principal Investigator: Jozef Vercruysse University Ghent
University Ghent
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP