Status:
ACTIVE_NOT_RECRUITING
Enterics for Global Health (EFGH)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Aga Khan University
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Shigella
Child
Eligibility:
All Genders
6-35 years
Brief Summary
Diarrhea remains a leading cause of death among young children, with the majority of diarrhea deaths occurring in low- and middle-income countries. Childhood diarrhea caused by a type of bacteria call...
Detailed Description
In low- and middle-income countries, nearly one third of children experience at least one episode of Shigella-attributable diarrhea during their first 2 years of life. In addition to it being a leadin...
Eligibility Criteria
Inclusion
- Child is 6-35 months of age
- Primary caregiver and child plan to remain at their current residence for at least the next 4 months
- Primary caregiver is able to provide informed consent (legal age or emancipated minor) and provides consent within a common language for which translations are available
- Child presents to health facility with diarrhea (≥3 abnormally loose or watery stools in the previous 24 hours) with or without the presence of blood
- Child resides within the pre-defined study area
- Fewer than 4 hours have passed since the child presented to a health facility
- Diarrhea episode is:
- Acute (onset within 7 days of study enrollment) and
- Represents a new episode (onset after at least 2 diarrhea-free days)
- Caregiver is willing to have child participate in follow-up visits at week 4 and month 3
- Willingness to have samples collected from the child (rectal swabs at enrollment)
- Site enrollment cap has not been met
- Child is not being referred to a non-EFGH facility at the time of screening
Exclusion
- Child is \< 6-35 months of age
- Child is \> 6-35 months of age
- Primary caregiver and child do not plan to remain at their current residence for at least the next 4 months
- Primary caregiver is not able to provide informed consent (legal age or emancipated minor)
- Primary caregiver does not provide consent within a common language for which translations are available
- Child does not present to health facility with diarrhea (≥3 abnormally loose or watery stools in the previous 24 hours) with or without the presence of blood
- Child does not reside within the pre-defined study area
- 4 or more hours have passed since the child presented to a health facility
- Diarrhea episode is not Acute (onset within 7 days of study enrollment)
- Diarrhea episode does not represent a new episode (onset after at least 2 diarrhea-free days)
- Caregiver is unwilling to have child participate in follow-up visits at week 4 and month 3
- Unwillingness to have samples collected from the child (rectal swabs at enrollment)
- Site enrollment cap has been met
- Child is being referred to a non-EFGH facility at the time of screening
Key Trial Info
Start Date :
August 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
9800 Patients enrolled
Trial Details
Trial ID
NCT06047821
Start Date
August 25 2022
End Date
April 30 2025
Last Update
January 14 2025
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Dhaka Medical College Hospital
Dhaka, Bangladesh
2
EFGH Field Clinic
Dhaka, Bangladesh
3
icddr,b Dhaka Hospital
Dhaka, Bangladesh
4
Mugda Medical College Hospital
Dhaka, Bangladesh