Status:
COMPLETED
Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Swiss Tropical & Public Health Institute
Conditions:
Soil-transmitted Helminth Infections
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retar...
Detailed Description
Background Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intelle...
Eligibility Criteria
Inclusion
- Subject, male or female, is 5-14 years of age
- Subject is otherwise in an healthy condition (medical history and physical examination)
- Parent(s)/guardians of subjects (or their legally-accepted representatives) signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study.
- Subject of ≥6 years has assented (agreed) to participate in the study.
- Subject of ≥12 has signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- The subject swallowed the entire drug (ALB 400 mg) under supervision
- Subject provides a stool sample of at least 9 grams
Exclusion
- Subject has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up
- Subject has any acute medical condition or is experiencing a severe concurrent medical condition
- Subject has a known hypersensitivity to benzimidazole drugs
- Subject has received an anthelminthic treatment within 90 of the start of the treatment.
- Subject vomited within 4 hours after drug administration
- Subject is unable to provide a stool sample at follow-up
Key Trial Info
Start Date :
August 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03465488
Start Date
August 15 2016
End Date
September 1 2019
Last Update
October 21 2019
Active Locations (4)
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1
Fiocruz - Research institute of Renê Rachou
Belo Horizonte, Minas Gerais, Brazil
2
Jimma University
Jimma, Ethiopia
3
National Institute of Public Health
Vientiane, Laos
4
The Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake, Pemba, Tanzania