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

NCT01087099 | Completed Phase 4

• 1 other identifier: 2008/322
• Study Type: interventional
• Target: 1,750
• Locations: 6 countries
• Sites: 6

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)

Outcome Measures

Primary Outcomes (1)

• Efficacy of albendazole

  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.

  14 to 30 days after treatment

Study Arms (1)

Albendazole

EXPERIMENTAL

Treatment with albendazole

Drug: Albendazole

Interventions

Albendazole DRUG

Treatment with albendazole

Albendazole

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Not willing to participate
• Unable to give samples for follow up
• Severe intercurrent medical condition
• Diarrhoea at first sampling

Sponsors & Collaborators

• University Ghent: lead
• World Health Organization: collaborator
• George Washington University: collaborator
• Commonwealth Scientific and Industrial Research Organisation, Division of Livestock Industries, Brisbane, Australia: collaborator
• University of Nottingham: collaborator
• Queensland Institute of Medical Research: collaborator

Study Sites (7)

Instituto René Rachou, Fundação Oswaldo Cruz

Minas Gerais, Brazil

Location

Institut Pasteur in Cambodia, Clinical Pathology Unit

Phnom Penh, Cambodia

Location

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

Yaoundé, Cameroon

Location

Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University

Jimma, Ethiopia

Location

Department of Gastrointestinal Sciences, Christian Medical College

Vellore, India

Location

Public Health Laboratory

Zanzibar, Tanzania

Location

National Institute for Malariology, Parasitology and Entomology

Hanoi, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 25299391 DERIVED

• 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.

  PMID: 22189084 DERIVED

• 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.

  PMID: 21468309 DERIVED

MeSH Terms

Interventions

Albendazole

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jozef Vercruysse

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 2, 2011

Record last verified: 2011-07

Locations

ET (1); IN (1); TA (1); VN (1); CA (1); BR (1)