NCT01087099

A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,750 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infections With Soil-Transmitted Helminths (STH)

Interventions

Type	Name	Description
DRUG	Albendazole	Treatment with albendazole

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2010-03-15
• Last updated: 2011-08-02

Locations

7 sites across 7 countries: Brazil, Cambodia, Cameroon, Ethiopia, India, Tanzania, Vietnam