PACTR202402529220760
Not yet recruiting
Phase 3
A Pragmatic Phase III Multi-Centre Clinical Trial to Evaluate the Safety and Effectiveness of a Single Dose of an Albendazole-Ivermectin Coformulation vs Albendazole for Preventive Chemotherapy of Soil-Transmitted Helminth Infections in School-Aged Children
aboratorios Liconsa SA0 sites20,000 target enrollmentFebruary 5, 2024
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Soil-transmitted helminths
- Sponsor
- aboratorios Liconsa SA
- Enrollment
- 20000
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 5 to 17 years old (included).
- •\- Height: over 90cm.
- •\- Parental acceptance to participate in the study by obtaining written informed consent approved by the Ethics Committee. Written assent will also be obtained from children according to the local national legislation. (In Kenya written assent will be obtained from children 12\-17 years old and in Ghana for children 15\-17 years old.)
Exclusion Criteria
- •\- Epidemiological risk of being infected by Loa loa.
- •\- Serious medical illness, per investigator’s criteria.
- •\- Any condition prevents the appropriate evaluation and follow\-up of the participant, per the investigator’s criteria.
- •\- Known hypersensitivity to any component of either study treatment.
- •\- Pregnant or first week post\-partum, reported by the participant during interview.
Outcomes
Primary Outcomes
Not specified
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