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

This study has been completed.

Sponsor:

Collaborators:

Ghent University, Faculty of Veterinary Medicine, Dpt of Virology, Parasitology and Immunology, Belgium

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

Information provided by:

University Ghent

ClinicalTrials.gov Identifier:

NCT01087099

First received: March 12, 2010

Last updated: July 30, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 12, 2010

Last Updated Date

July 30, 2011

Start Date ^ICMJE

January 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy of albendazole [ Time Frame: 14 to 30 days after treatment ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01087099 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infections With Soil-Transmitted Helminths (STH)

Intervention ^ICMJE

Drug: Albendazole

Treatment with albendazole

Study Arm (s)

Experimental: Albendazole

Treatment with albendazole

Intervention: Drug: Albendazole

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1750

Completion Date

March 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil, Cambodia, Cameroon, Ethiopia, India, Tanzania, Vietnam

Administrative Information

NCT Number ^ICMJE

NCT01087099

Other Study ID Numbers ^ICMJE

2008/322

Has Data Monitoring Committee

Responsible Party

Jozef Vercruysse, University Ghent

Study Sponsor ^ICMJE

University Ghent

Collaborators ^ICMJE

Ghent University, Faculty of Veterinary Medicine, Dpt of Virology, Parasitology and Immunology, Belgium
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

Investigators ^ICMJE

Principal Investigator:

Jozef Vercruysse

University Ghent

Information Provided By

University Ghent

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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