Status:
COMPLETED
Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
Public Health Laboratory Ivo de Carneri
Conditions:
Trichuriasis
Ascariasis
Eligibility:
All Genders
6-12 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 compared to albendazole monot...
Detailed Description
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 compared to albendazole monot...
Eligibility Criteria
Inclusion
- individuals aged 6-12 years (confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Exclusion
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of \>38.0°C), severe anaemia (haemoglobin level of \<80 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., moxidectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- pregnancy (female participants aged 10-12 years)
- concurrent participation in other clinical trials
Key Trial Info
Start Date :
May 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2024
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06188715
Start Date
May 14 2024
End Date
August 5 2024
Last Update
September 19 2025
Active Locations (1)
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1
Public Health Laboratory Ivo de Carneri
Chake Chake, Tanzania