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

NCT ID: NCT01087099

Last Updated: 2011-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-03-31

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.

Conditions

Infections With Soil-Transmitted Helminths (STH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albendazole

Treatment with albendazole

Group Type: EXPERIMENTAL

Albendazole

Intervention Type: DRUG

Treatment with albendazole

Interventions

Albendazole

Treatment with albendazole

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: collaborator

Queensland Institute of Medical Research

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

University Ghent

Principal Investigators

Jozef Vercruysse

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Instituto René Rachou, Fundação Oswaldo Cruz

Minas Gerais, , Brazil

Institut Pasteur in Cambodia, Clinical Pathology Unit

Phnom Penh, , Cambodia

Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I

Yaoundé, , Cameroon

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

Public Health Laboratory

Zanzibar, , Tanzania

National Institute for Malariology, Parasitology and Entomology

Hanoi, , Vietnam

Countries

Brazil; Cambodia; Cameroon; Ethiopia; India; Tanzania; Vietnam

References

Levecke B, Montresor A, Albonico M, Ame SM, Behnke JM, Bethony JM, Noumedem CD, Engels D, Guillard B, Kotze AC, Krolewiecki AJ, McCarthy JS, Mekonnen Z, Periago MV, Sopheak H, Tchuem-Tchuente LA, Duong TT, Huong NT, Zeynudin A, Vercruysse J. Assessment of anthelmintic efficacy of mebendazole in school children in six countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3204. doi: 10.1371/journal.pntd.0003204. eCollection 2014 Oct.

Reference Type: DERIVED

PMID: 25299391 (View on PubMed)

Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.

Reference Type: DERIVED

PMID: 22189084 (View on PubMed)

Vercruysse J, Behnke JM, Albonico M, Ame SM, Angebault C, Bethony JM, Engels D, Guillard B, Nguyen TV, Kang G, Kattula D, Kotze AC, McCarthy JS, Mekonnen Z, Montresor A, Periago MV, Sumo L, Tchuente LA, Dang TC, Zeynudin A, Levecke B. Assessment of the anthelmintic efficacy of albendazole in school children in seven countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2011 Mar 29;5(3):e948. doi: 10.1371/journal.pntd.0000948.

Reference Type: DERIVED

PMID: 21468309 (View on PubMed)

Other Identifiers

2008/322

Identifier Type: -

Identifier Source: org_study_id