Status:
UNKNOWN
Evaluation of an AI-DP for STH Deworming Programs: a Study Protocol
Lead Sponsor:
Enaiblers AB
Collaborating Sponsors:
Jimma University
Ministry of Health, Uganda
Conditions:
Soil Transmitted Helminths
Schistosomiasis Mansoni
Eligibility:
All Genders
5-14 years
Brief Summary
The goal of this observational study is to test a new AI diagnostic tool for detection, specification and quantification of parasitic infections (Ascaris, Trichuris, hookworm and S. Mansoni) in School...
Detailed Description
Manual screening of a Kato-Katz (KK) thick stool smear remains the current standard to monitor the impact of large-scale deworming programs against soil-transmitted helminths (STHs). To improve this d...
Eligibility Criteria
Inclusion
- Subject, male or female, is 5-14 years of age
- Parent(s)/guardian(s) of subject signed an informed consent document indicating that they understand the purpose and procedures required for the study and that they are willing to have their child participate in the study
- Subject of ≥6 (Ethiopia) /8 (Uganda) years old has assented to participate in the study\*
- Subject of ≥12 years old has signed an informed consent document indicating that they understand the purpose of the study and procedures required for the study, and are willing to participate in the study (Ethiopia only)\*
- Subject has provided a stool sample of minimum 5 grams
Exclusion
- Subject has active diarrhoea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up.
- Subject is experiencing a severe concurrent medical condition or has an acute medical condition
- Subject has received anthelmintic treatment within 90 days prior to the start of the study
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06055530
Start Date
October 1 2023
End Date
July 1 2024
Last Update
October 2 2023
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