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

Primary Purpose

Infections With Soil-Transmitted Helminths (STH)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Albendazole
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections With Soil-Transmitted Helminths (STH)

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto René Rachou, Fundação Oswaldo Cruz
  • Institut Pasteur in Cambodia, Clinical Pathology Unit
  • Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I
  • Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University
  • Department of Gastrointestinal Sciences, Christian Medical College
  • Public Health Laboratory
  • National Institute for Malariology, Parasitology and Entomology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Albendazole

Arm Description

Treatment with albendazole

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2010
Last Updated
July 30, 2011
Sponsor
University Ghent
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01087099
Brief Title
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Acronym
WORMCON
Official Title
A Multinational Trial of the Efficacy of Albendazole Against Soil-transmitted Nematode Infections in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Ghent
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections With Soil-Transmitted Helminths (STH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Albendazole
Arm Type
Experimental
Arm Description
Treatment with albendazole
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
Treatment with albendazole
Primary Outcome Measure Information:
Title
Efficacy of albendazole
Description
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.
Time Frame
14 to 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozef Vercruysse
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto René Rachou, Fundação Oswaldo Cruz
City
Minas Gerais
Country
Brazil
Facility Name
Institut Pasteur in Cambodia, Clinical Pathology Unit
City
Phnom Penh
Country
Cambodia
Facility Name
Centre for Schistosomiasis and Parasitology, Faculty of Sciences, University of Yaoundé I
City
Yaounde
Country
Cameroon
Facility Name
Department of Medical Laboratory Sciences and Pathology , College of Public Health and Medical Sciences, Jimma University
City
Jimma,
Country
Ethiopia
Facility Name
Department of Gastrointestinal Sciences, Christian Medical College
City
Vellore
Country
India
Facility Name
Public Health Laboratory
City
Zanzibar
Country
Tanzania
Facility Name
National Institute for Malariology, Parasitology and Entomology
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
25299391
Citation
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.
Results Reference
derived
PubMed Identifier
22189084
Citation
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.
Results Reference
derived
PubMed Identifier
21468309
Citation
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.
Results Reference
derived

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

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