Status:
COMPLETED
Efficacy and Safety of MOX/ALB Co-administration
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Conditions:
Trichuriasis
Ascariasis
Eligibility:
All Genders
12-60 years
Phase:
PHASE3
Brief Summary
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherap...
Detailed Description
This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standar...
Eligibility Criteria
Inclusion
- Aged between 12 and 60 years
- Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-60 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 at follow-up assessment 14-21 days 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
- 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
- Known or suspected infection with Loa loa
- History of acute or severe chronic disease
- Abnormal liver function assessed by multiple biochemical blood-based analyses
- 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 3 months
- Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin)
- Taking medication with known contraindication to or interaction with study drugs
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04726969
Start Date
June 15 2021
End Date
September 9 2021
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
Abidjan, Côte d’Ivoire