A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children (WORMCON)
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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 |
- 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 |
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| 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 | |
| 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:
|
Nematode Infections Helminthiasis Parasitic Diseases Albendazole Anticestodal Agents Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013