Status:
COMPLETED
An Epidemiological Surveillance Study to Determine the Incidence of ETEC in Children and Infants in Lusaka
Lead Sponsor:
Centre for Infectious Disease Research in Zambia
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Scandinavian Biopharma AB
Conditions:
Diarrhea Toddlers
Escherichia Coli Diarrhea
Eligibility:
All Genders
Up to 36 years
Brief Summary
Diarrhoea is the one of the top five leading causes of death among children below the age of five years, globally. It is estimated that one in ten deaths in children under five is attributed to diarrh...
Detailed Description
This study seeks to determine diarrhoea aetiology, calculate the incidence of moderate-to-severe ETEC-associated diarrhea, and describe the frequency of ETEC colonization factors and enterotoxin types...
Eligibility Criteria
Inclusion
- A child \< 36 months old at the time of enrolment.
- A child presenting with diarrhoea (i.e. \> 3 episodes of looser than normal stools in 24 hours) at a health facility within the study catchment area and in possession of a study ID number.
- Parents of eligible children, able to understand the study information and give informed consent by signature or thumbprint. (NB. illiterate participants will be able to give consent in the presence of an impartial witness)
- Children living within the study catchment area served by each participating health facility and in possession of a study ID number
- The parent/s who is willing to comply with all stipulated study procedures.
- Parents who are willing to allow their child to submit a stool sample for testing.
Exclusion
- Children presenting to the health facility without a study ID number
- Any child born after the Census has taken place
- Any child currently participating in the OEV124 study
Key Trial Info
Start Date :
October 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
6828 Patients enrolled
Trial Details
Trial ID
NCT04838587
Start Date
October 15 2020
End Date
October 15 2021
Last Update
July 20 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Chawama First level hospital
Lusaka, Zambia, 10101
2
George Clinic
Lusaka, Zambia, 10101
3
Kanyama First Level Hospital
Lusaka, Zambia, 10101
4
Matero Clinical Research Site, Chainda South CRS
Lusaka, Zambia, 10101