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

Phase 4

Completed

• Conditions: Infections With Soil-Transmitted Helminths (STH)
• Interventions: Drug: Albendazole

• Registration Number: NCT01087099
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-30
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albendazole	Albendazole	Treatment with albendazole

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

Institut Pasteur in Cambodia, Clinical Pathology Unit; 🇰🇭 Phnom Penh, Cambodia

Instituto René Rachou, Fundação Oswaldo Cruz; 🇧🇷 Minas Gerais, Brazil

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

Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I; 🇨🇲 Yaounde, Cameroon

Public Health Laboratory; 🇹🇿 Zanzibar, Tanzania

National Institute for Malariology, Parasitology and Entomology; 🇻🇳 Hanoi, Vietnam