Status:
COMPLETED
Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
Conditions:
Trichuriasis
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg)...
Detailed Description
In view that efficacy of co-administered ivermectin (IVM) and albendazole (ALB) has been found to vary between different settings the rationale of this parallel open-label randomized controlled superi...
Eligibility Criteria
Inclusion
- Written informed consent for participation signed from caregivers; and written assent by participants.
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and at follow-up assessment 14-21 days after treatment.
- Willing to be examined by a study nurse/physician prior to treatment.
- At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.
Exclusion
- Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.
- Recent use of anthelmintic drug (within past 4 weeks).
- Attending other experimental research studies.
- Known allergy to study medications (i.e. benzimidazole or ivermectin).
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT06037876
Start Date
October 9 2023
End Date
November 14 2023
Last Update
April 10 2024
Active Locations (1)
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1
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala, Uganda, P.O.Box 1661