NCT07629154

Brief Summary

This study is an observational multi-country cohort study that aims to build algorithms that can identify children between 5 and 16 years of age admitted for proven or suspected sepsis who are at risk of mortality after they are discharged in East Africa. In low- and middle-income countries, about 5% of children discharged after hospitalization for sepsis will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work that developed and evaluated models and the Smart Discharges program to predict, during hospitalization, an individual child's risk of recurrent illness and mortality, as well as to provide additional post-discharge support to at-risk children. Participants will be enrolled from facilities once they are admitted, collecting clinical and social variables. They will then be followed until 6 months post-discharge to understand what happens to them after they return home. This data will be evaluated to identify which variables collected at facilities can be predictive of mortality and recurrent illness after discharge.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
5 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2024Apr 2027

Study Start

First participant enrolled

January 2, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

3.2 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

pediatricssepsisrisk-predictioncritical carepost-dischargepatient discharge

Outcome Measures

Primary Outcomes (1)

  • Post-discharge mortality

    Discharge until 6 months post-discharge

Secondary Outcomes (1)

  • Post-discharge readmission

    Discharge until 6 months post-discharge

Study Arms (1)

Pediatric patients 5-16 years of age

Pediatric patients admitted to a study site with suspected or proven infection

Other: No Intervention: Observational Cohort

Interventions

This is a non-interventional study

Pediatric patients 5-16 years of age

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population is children admitted to hospital facilities with suspected or proven sepsis between 5-16 years of age in the catchment area of the 8 study sites: Mbarara Regional Referral Hospital (Uganda), Jinja Regional Referral Hospital (Uganda), Uganda Martyrs Ibanda Hospital (Uganda), Holy Innocents Children's Hospital (Uganda), Sekou-Toure Regional Referral Hospital (Tanzania), Bugando Medical Centre (Tanzania), Masaka Hospital (Rwanda), University Teaching Hospital of Kigali (Rwanda), Ruhengeri Referral Hospital (Rwanda).

You may qualify if:

  • Age between 0 and 16 years admitted to pediatric ward of hospital for proven or suspected infection
  • Provide informed consent
  • Ability to provide contact information (phone number or address) for phone or in-person follow-up

You may not qualify if:

  • Child lives outside of the catchment area of a study site
  • Admitted for elective procedures, trauma, or short-term observation
  • Language barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California, San Francisco

San Francisco, California, 94117, United States

NOT YET RECRUITING

Weill Cornell Medicine

Ithaca, New York, 14850, United States

NOT YET RECRUITING

University of Washington

Seattle, Washington, 98195, United States

NOT YET RECRUITING

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 2X8, Canada

ACTIVE NOT RECRUITING

The Rwanda Paediatric Association

Kigali, Rwanda

RECRUITING

Catholic University Of Health And Allied Sciences

Mwanza, Tanzania

RECRUITING

WALIMU

Mbarara, Uganda

COMPLETED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew Wiens, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

January 2, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

After the study period, a de-identified copy of the data will be prepared for deposition in a repository with open access with proper governance mechanisms. We will make every effort to prevent re-identification of subjects by coding data that has the potential of being identifiable. For example, we will convert all dates into meaningful decimal numbers (date of birth into days since birth and date of recruitment will be reduced to month of recruitment) and all locations will be coded into data that is useful but not specific (such as address converted to distance and direction from facility). We will ensure that data elements with small numbers of subjects (less than 10) will be coded or lumped to avoid identification. The de-identified study data will be made available using a data hosting service (e.g., Dataverse, Vivli, etc.)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be deposited to an open access repository with moderated access within 2 years of study completion
Access Criteria
Moderated access on a case-by-case basis.

Locations