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

• ClinicalTrials.gov Identifier: NCT01087099
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: August 2, 2011
• Sponsor: University Ghent
• Collaborators: World Health Organization; George Washington University; Commonwealth Scientific and Industrial Research Organisation, Australia; University of Nottingham; Queensland Institute of Medical Research
• Information provided by: University Ghent

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infections With Soil-Transmitted Helminths (STH)	Drug: Albendazole	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1750 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
• Study Start Date: January 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Albendazole; Treatment with albendazole	Drug: Albendazole; Treatment with albendazole

Outcome Measures

Primary Outcome Measures :

1. Efficacy of albendazole [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

Instituto René Rachou, Fundação Oswaldo Cruz

Minas Gerais, Brazil

Cambodia

Institut Pasteur in Cambodia, Clinical Pathology Unit

Phnom Penh, Cambodia

Cameroon

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

Yaounde, Cameroon

Ethiopia

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

Jimma,, Ethiopia

India

Department of Gastrointestinal Sciences, Christian Medical College

Vellore, India

Tanzania

Public Health Laboratory

Zanzibar, Tanzania

Vietnam

National Institute for Malariology, Parasitology and Entomology

Hanoi, Vietnam

Sponsors and Collaborators

University Ghent

World Health Organization

George Washington University

Commonwealth Scientific and Industrial Research Organisation, Australia

University of Nottingham

Queensland Institute of Medical Research

Investigators

• Principal Investigator: Jozef Vercruysse; University Ghent

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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-Tchuenté 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.

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.

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, Tchuenté 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.

• Responsible Party: Jozef Vercruysse, University Ghent
• ClinicalTrials.gov Identifier: NCT01087099
• Other Study ID Numbers: 2008/322
• First Posted: March 15, 2010
• Last Update Posted: August 2, 2011
• Last Verified: July 2011

Additional relevant MeSH terms:

Infection; Communicable Diseases; Nematode Infections; Helminthiasis; Parasitic Diseases; Albendazole; Anthelmintics; Antiparasitic Agents; Anti-Infective Agents; Anticestodal Agents; Antiplatyhelmintic Agents; Antiprotozoal Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents