Infections With Soil-Transmitted Helminths (STH)
Conditions
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.
Interventions
DRUGAlbendazole
Treatment with albendazole
Sponsors
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
University Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of albendazole | 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. |
Countries
Brazil, Cambodia, Cameroon, Ethiopia, India, Tanzania, Vietnam
Outcome results
None listed