Status:
COMPLETED
Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC
Lead Sponsor:
Jennifer Keiser
Collaborating Sponsors:
Public Health Laboratory Ivo de Carneri
Conditions:
Trichuriasis
Ascariasis
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief Summary
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety...
Detailed Description
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and ac...
Eligibility Criteria
Inclusion
- individuals aged 2-5 years (24-71 months; 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 \<70 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., ivermectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- concurrent participation in other clinical trials
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06184399
Start Date
June 5 2024
End Date
August 9 2024
Last Update
September 22 2025
Active Locations (1)
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1
Public Health Laboratory Ivo de Carneri
Chake Chake, Tanzania