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Trial record 1 of 1 for:    NCT01087099
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A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children (WORMCON)

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ClinicalTrials.gov Identifier: NCT01087099
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : August 2, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Infections With Soil-Transmitted Helminths (STH) Drug: Albendazole Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Study Start Date : January 2009
Primary Completion Date : December 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Albendazole
Treatment with albendazole
Drug: Albendazole
Treatment with albendazole

Outcome Measures

Primary Outcome Measures :
  1. Efficacy of albendazole [ Time Frame: 14 to 30 days after treatment ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT01087099

Instituto René Rachou, Fundação Oswaldo Cruz
Minas Gerais, Brazil
Institut Pasteur in Cambodia, Clinical Pathology Unit
Phnom Penh, Cambodia
Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I
Yaounde, Cameroon
Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University
Jimma,, Ethiopia
Department of Gastrointestinal Sciences, Christian Medical College
Vellore, India
Public Health Laboratory
Zanzibar, Tanzania
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, Australia
University of Nottingham
Queensland Institute of Medical Research
Principal Investigator: Jozef Vercruysse University Ghent
More Information

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
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Communicable Diseases
Nematode Infections
Parasitic Diseases
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents