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

NCT01087099 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1750

Last updated 2011-08-02

No results posted yet for this study

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

DRUG

Albendazole

Treatment with albendazole

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia

    collaborator UNKNOWN

  • University of Nottingham

    collaborator OTHER

  • Queensland Institute of Medical Research

    collaborator OTHER

  • University Ghent

    lead OTHER

Principal Investigators

  • Jozef Vercruysse · University Ghent

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • Brazil
  • Cambodia
  • Cameroon
  • Ethiopia
  • India
  • Tanzania
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01087099 on ClinicalTrials.gov