Diarrhea Clinical Trial
— EFGHOfficial title:
The Incidence and Burden of Shigella Diarrhea in Children Aged 6-35 Months: the Enterics for Global Health (EFGH) - Shigella Burden Study
NCT number | NCT06047821 |
Other study ID # | INV-01665 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 25, 2022 |
Est. completion date | May 31, 2025 |
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 called "Shigella" is responsible for an estimated 60,000 deaths each year and may cause particularly severe illness among children. Currently, there are several promising vaccines to prevent Shigella diarrhea in development, but key information is still needed to inform future vaccine studies. The purpose of this study, titled Enterics for Global Health (or the "EFGH"), is to determine the number and rate of new cases of Shigella diarrhea among children 6 to 35 months of age presenting to health facilities with diarrhea or dysentery. Over a two-year period, the EFGH study will enroll 1,400 children from each of the seven countries: Peru, Pakistan, Bangladesh, Mali, Malawi, Kenya, and The Gambia (9,800 children total).
Status | Recruiting |
Enrollment | 9800 |
Est. completion date | May 31, 2025 |
Est. primary completion date | December 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility | Inclusion Criteria: 1. Child is 6-35 months of age 2. Primary caregiver and child plan to remain at their current residence for at least the next 4 months 3. 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 4. 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 5. Child resides within the pre-defined study area 6. Fewer than 4 hours have passed since the child presented to a health facility 7. Diarrhea episode is: - Acute (onset within 7 days of study enrollment) and - Represents a new episode (onset after at least 2 diarrhea-free days) 8. Caregiver is willing to have child participate in follow-up visits at week 4 and month 3 9. Willingness to have samples collected from the child (rectal swabs at enrollment) 10. Site enrollment cap has not been met 11. Child is not being referred to a non-EFGH facility at the time of screening Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Dhaka Medical College Hospital | Dhaka | |
Bangladesh | EFGH Field Clinic | Dhaka | |
Bangladesh | icddr,b Dhaka Hospital | Dhaka | |
Bangladesh | Mugda Medical College Hospital | Dhaka | |
Bangladesh | Sir Salimullah Medical College Hospital | Dhaka | |
Gambia | Basse Hospital | Basse Santa Su | Upper River Region |
Gambia | Gambisara Health Centre (HC) | Basse Santa Su | Upper River Region |
Kenya | Abidha Health Center | Siaya | |
Kenya | Akala Health Center | Siaya | |
Kenya | Bar Agulu Health Center | Siaya | |
Kenya | Dienya Health Centre | Siaya | |
Kenya | Lwak Mission Hospital | Siaya | |
Kenya | Ongielo Health Centre | Siaya | |
Kenya | Siaya County Referral Hospital | Siaya | |
Kenya | Ting Wangi Health Center | Siaya | |
Kenya | Wagai Health Center | Siaya | |
Malawi | Ndirande Health Centre | Blantyre | |
Mali | Asacodjeneka Cscom | Bamako | |
Mali | Asacodjip Cscom | Bamako | |
Mali | Banconi CSCOM (ASACOBA) | Bamako | |
Mali | CSREF Commune 1 | Bamako | |
Pakistan | Abbasi Shaheed Hospital | Karachi | |
Pakistan | Ali Akbar Shah Center | Karachi | |
Pakistan | Bhains colony AKU site | Karachi | |
Pakistan | Khidmat e Alam Medical Centre | Karachi | |
Pakistan | Sindh Government Hospital, Ibrahim Hyderi | Karachi | |
Pakistan | Sindh Government Hospital, Korangi | Karachi | |
Peru | America Health Post | Iquitos | Maynas |
Peru | Hospital de Apoloyo | Iquitos | Maynas |
Peru | Modelo Health Post | Iquitos | Maynas |
Peru | Progreso Health Post | Iquitos | Maynas |
Peru | San Juan Health Post | Iquitos | Maynas |
Peru | Santo Tomas Health Post | Iquitos | Maynas |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Aga Khan University, Asociacion Benefica Prisma, Bill and Melinda Gates Foundation, Center for Vaccine Development - Mali, International Centre for Diarrhoeal Disease Research, Bangladesh, Kenya Medical Research Institute, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Medical Research Council Unit, The Gambia, University of Maryland, Baltimore, University of Virginia |
Bangladesh, Gambia, Kenya, Malawi, Mali, Pakistan, Peru,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Shigella incidence | The primary outcome measure is Shigella incidence, defined as incident diarrhea among children enrolled at health clinics attributable to Shigella by microbiological methods (culture or qPCR) divided by the estimated population living in the catchment area. Incidence will be reported as crude incidence as well as adjusted for healthcare seeking and the percentage of children who were enrolled. | At enrollment in the study (cross-sectional) | |
Secondary | Antimicrobial susceptibility | Antimicrobial susceptibility will be computed separately for Ampicillin, Azithromycin, Ceftriaxone, Ciprofloxacin, Nalidixic Acid, Pivmecillinam, and Trimethoprim-Sulfamethoxazole and defined as intermediate or resistant according to the most recent Clinical and Laboratory Standards Institute (CLSI) interpretive standards at the time of data analysis. | At enrollment in the study (cross-sectional) | |
Secondary | Cost per episode treated | Cost per episode treated will be calculated using the direct and indirect financial costs and total economic costs of illness per outpatient and inpatient episode of Shigella-associated diarrhea from the household and, separately, payer perspectives. | 3 months | |
Secondary | Death | Death: all cause mortality during follow-up among enrolled children. | 3 months | |
Secondary | Hospitalization | Hospitalization will be defined as an overnight stay (child was on the ward from at least 12am to 6am) that occurs during follow-up among enrolled children | 3 months | |
Secondary | Persistent diarrhea (index episode) | Persistent diarrhea will be defined as 14 or more days of diarrhea (starting from the date at which the diarrhea first started (as opposed to date at presentation to an EFGH facility) and concluding at the last day of diarrhea prior to the two consecutive diarrhea-free days concluding the episode. | 3 months | |
Secondary | Diarrhea/dysentery recurrence | Diarrhea/dysentery recurrence will be defined as new diarrhea/dysentery episodes (>48 hours after a diarrhea-free period). | 3 months | |
Secondary | Change in linear growth | Change in mean length/height-for-age z-score (?LAZ/?HAZ) from enrollment to 3 months. The 2006 World Health Organization (WHO) reference population will be used to calculate HAZ from the average of two repeated length/height (cm) measures per child per time point | 3 months |
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