Infections With Soil-Transmitted Helminths (STH) Clinical Trial
— WORMCONOfficial title:
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
| Verified date | July 2011 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1750 |
| Est. completion date | March 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 14 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Instituto René Rachou, Fundação Oswaldo Cruz | Minas Gerais | |
| Cambodia | Institut Pasteur in Cambodia, Clinical Pathology Unit | Phnom Penh | |
| Cameroon | Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I | Yaounde | |
| Ethiopia | Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University | Jimma, | |
| India | Department of Gastrointestinal Sciences, Christian Medical College | Vellore | |
| Tanzania | Public Health Laboratory | Zanzibar | |
| Vietnam | National Institute for Malariology, Parasitology and Entomology | Hanoi |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Commonwealth Scientific and Industrial Research Organisation, Australia, George Washington University, Ghent University, Faculty of Veterinary Medicine, Dpt of Virology, Parasitology and Immunology, Belgium, Queensland Institute of Medical Research, University of Nottingham, World Health Organization |
Brazil, Cambodia, Cameroon, Ethiopia, India, Tanzania, Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy of albendazole | 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. | 14 to 30 days after treatment | No |