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

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ClinicalTrials.gov Identifier: NCT01087099
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : August 2, 2011
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE March 12, 2010
First Posted Date  ICMJE March 15, 2010
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infections With Soil-Transmitted Helminths (STH)
Intervention  ICMJE Drug: Albendazole
Treatment with albendazole
Study Arms  ICMJE 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
 (submitted: March 12, 2010)
1750
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Cambodia,   Cameroon,   Ethiopia,   India,   Tanzania,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087099
Other Study ID Numbers  ICMJE 2008/322
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jozef Vercruysse, University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE
  • World Health Organization
  • George Washington University
  • Commonwealth Scientific and Industrial Research Organisation, Australia
  • University of Nottingham
  • Queensland Institute of Medical Research
Investigators  ICMJE
Principal Investigator: Jozef Vercruysse University Ghent
PRS Account University Ghent
Verification Date July 2011

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