Status:
COMPLETED
Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
Public Health Laboratory Ivo de Carneri
Conditions:
Trichuriasis
Ascariasis
Eligibility:
All Genders
12-19 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and ...
Detailed Description
We designed a non-inferiority trial to show that co-administered moxidectin and albendazole is non-inferior compared to co-administered ivermectin and albendazole in adolescents aged 12-19 years on Pe...
Eligibility Criteria
Inclusion
- Aged between 12 and 19 years.
- Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 years of age); and written assent by underage participant.
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (14-21 days, 5-6 weeks and 3 months after treatment).
- Willing to be examined by a study physician prior to treatment.
- At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 48 EPG.
Exclusion
- No written informed consent by individual or caregiver and/or no written assent by minors
- Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, severe anemia (below 80g/l Hb according to WHO) upon initial clinical assessment.
- History of acute or severe chronic disease.
- Recent use of anthelmintic drug (within past 4 weeks).
- Attending other clinical trials during the study.
- Pregnancy, lactating, and/or planning to become pregnant within the next 6 months.
- Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin).
- Taking medication with known interaction on study drugs.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT04700423
Start Date
March 1 2021
End Date
September 22 2021
Last Update
December 5 2024
Active Locations (1)
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1
Public Health Laboratory Ivo de Carneri
Chake Chake, Pemba, Tanzania