NCT04304235

Brief Summary

Sepsis is the leading cause of death and disability in children, every hour of delay in treatment is associated with greater organ damage and ultimately death. The challenges, especially in poor countries, are the delays in diagnosis and the inability to identify children in urgent need of treatment.To circumvent these challenges, we propose the development and clinical evaluation of a trigger tool that will reduce the time to diagnosis and prompt the timely initiation of life-saving treatment. The key innovations are 1) a data-driven approach to rapid diagnosis of sepsis severity and 2) a low- cost digital tagging system to track the time to treatment. The tool will require minimal cost, clinical expertise and training or time to use. The tool will identify high risk children and reduce time to treatment. The digital platform (mobile device and dashboard) will create a low-cost, highly scalable solution for children with sepsis.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
18,693

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable sepsis

Geographic Reach
2 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 13, 2025

Completed
Last Updated

May 13, 2025

Status Verified

April 1, 2025

Enrollment Period

3.2 years

First QC Date

March 3, 2020

Results QC Date

February 7, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

triagedeveloping countries

Outcome Measures

Primary Outcomes (1)

  • Time to Administration of an Appropriate Antimicrobial

    Time in minutes to administer an appropriate antimicrobial, which includes at least one antibiotic or antimalarial (treatment determined and administered by hospital staff). The time is measured from when the child arrives at the facility (time of the first registration) until the antimicrobial administration is started.

    1 day

Other Outcomes (5)

  • Readmission

    7 days

  • Mortality

    7 days

  • Admission

    12 hours

  • +2 more other outcomes

Study Arms (7)

Kenya intervention baseline

ACTIVE COMPARATOR

Hospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.

Other: Emergency Triage and Treatment (ETAT) guidelines

Kenya intervention implementation

EXPERIMENTAL

Hospital nurses will triage participants using the digital triage tool (mhealth intervention).

Device: Pediatric Rapid Sepsis Trigger (PRST) tool

Kenya control baseline

ACTIVE COMPARATOR

Hospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.

Other: Emergency Triage and Treatment (ETAT) guidelines

Kenya control implementation

ACTIVE COMPARATOR

Hospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.

Other: Emergency Triage and Treatment (ETAT) guidelines

Uganda intervention baseline

ACTIVE COMPARATOR

Hospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.

Other: Emergency Triage and Treatment (ETAT) guidelines

Uganda intervention implementation

EXPERIMENTAL

Hospital nurses will triage participants using the digital triage tool (mhealth intervention)

Device: Pediatric Rapid Sepsis Trigger (PRST) tool

Uganda control implementation

ACTIVE COMPARATOR

Hospital nurses will triage participants using the Emergency Triage and Treatment (ETAT) guidelines, the triage policy that is currently in place at the study hospital sites.

Other: Emergency Triage and Treatment (ETAT) guidelines

Interventions

The digital platform consists of a mobile application integrating a pulse oximetry sensor attached to this device, with embedded smart algorithms that predict a critically ill state, or level of risk (below) in a child presenting at the hospital. The platform also includes an interactive dashboard located in strategic locations (e.g., laboratory, consultation rooms), which connects to the mobile application through a secure local network and displays the triage data to provide real-time monitoring for the physicians who manage the patients.

Kenya intervention implementationUganda intervention implementation

These are the triage guidelines currently applied in the study hospital sites. This will be the comparator group.

Kenya control baselineKenya control implementationKenya intervention baselineUganda control implementationUganda intervention baseline

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All paediatric outpatients presenting to the study hospitals for medical treatment. The lower age limit will include children aged from 0 days, and the upper age limit will be in accordance to respective hospitals' practice for paediatric admissions (this may be 12, 15 or 19 years).
  • Informed parental/guardian consent provided.
  • Assent from children older than 13 years in addition to parental/guardian consent provided.

You may not qualify if:

  • Patients presenting to the outpatient department for elective cases (e.g. elective surgery or change of dressing) or for clinical review appointment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kiambu County Referral Hospital

Nairobi, Kenya

Location

Mbagathi County Hospital

Nairobi, Kenya

Location

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Related Publications (4)

  • Ansermino JM, Pillay Y, Tagoola A, Zhang C, Dunsmuir D, Kamau S, Kigo J, Agaba C, Aye IA, Hwang B, Novakowski SK, Huxford C, Wiens MO, Kimutai D, Ouma M, Ahmed I, Mwaniki P, Oyella F, Tenywa E, Nambuya H, Toliva BO, Kenya-Mugisha N, Kissoon N, Akech S; Pediatric Sepsis CoLab. Implementation of Smart Triage combined with a quality improvement program for children presenting to facilities in Kenya and Uganda: An interrupted time series analysis. PLOS Digit Health. 2025 Mar 10;4(3):e0000466. doi: 10.1371/journal.pdig.0000466. eCollection 2025 Mar.

  • Li ECK, Tagoola A, Komugisha C, Nabweteme AM, Pillay Y, Ansermino JM, Khowaja AR. Cost-effectiveness analysis of Smart Triage, a data-driven pediatric sepsis triage platform in Eastern Uganda. BMC Health Serv Res. 2023 Aug 31;23(1):932. doi: 10.1186/s12913-023-09977-5.

  • Li ECK, Grays S, Tagoola A, Komugisha C, Nabweteme AM, Ansermino JM, Mitton C, Kissoon N, Khowaja AR. Cost-effectiveness analysis protocol of the Smart Triage program: A point-of-care digital triage platform for pediatric sepsis in Eastern Uganda. PLoS One. 2021 Nov 17;16(11):e0260044. doi: 10.1371/journal.pone.0260044. eCollection 2021.

  • Mawji A, Li E, Komugisha C, Akech S, Dunsmuir D, Wiens MO, Kissoon N, Kenya-Mugisha N, Tagoola A, Kimutai D, Bone JN, Dumont G, Ansermino JM. Smart triage: triage and management of sepsis in children using the point-of-care Pediatric Rapid Sepsis Trigger (PRST) tool. BMC Health Serv Res. 2020 Jun 3;20(1):493. doi: 10.1186/s12913-020-05344-w.

MeSH Terms

Conditions

SepsisInfections

Interventions

Equipment and SuppliesTherapeuticsGuidelines as Topic

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

Simultaneous recruitment across countries disrupted by COVID-19 pandemic.

Results Point of Contact

Title
J Mark Ansermino
Organization
The University of British Columbia

Study Officials

  • John M Ansermino

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Due to the clinical pre-post intervention design, masking will not be possible.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: This is a pre-post intervention study involving pediatric outpatients at Jinja Hospital in Jinja, Uganda, and Mbagathi Hospital in Nairobi, Kenya. The study has three phases: (I) Baseline Period: data is collected on key predictors and outcomes before implementation of the digital triage tool, (II) Interphase Period: model/technology development and usability testing, (III) Intervention Period: data is collected on key predictors and outcomes after implementation of the digital triage tool. Patients who present to the study hospitals in seek of medical care for an acute illness during Phase I will be part of the baseline cohort. Patients who present to the study hospitals in seek of medical care for an acute illness during Phase III will be part of the interventional cohort. A third hospital site, Kiambu Hospital in Nairobi Kenya, will serve as a control hospital, and will only participate in Phase I for the entire duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 11, 2020

Study Start

April 27, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 13, 2025

Results First Posted

May 13, 2025

Record last verified: 2025-04

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. The de-identified study data will be made publicly available using the Harvard Dataverse (https://dataverse.harvard.edu/), which is the data repository for KWTRP, and a URL will be made accessible. To enhance visibility, sharing and collating datasets with other collaborating sites for increased usability/re-use, de-identified will also be shared availed to reputable data hosting service such as the INDEPTH Data Repository (http://www.indepth-ishare.org/index.php/home), or through the newly established Pediatric Sepsis CoLab (sponsored by the World Federation of Pediatric Critical and Intensive care Societies).

Time Frame
Data will be made available within 12 months following completion of the study.
Access Criteria
Sharing and access will be managed and subject to institutional agreements (Kenya Medical Research Institute, The University of British Columbia, Makerere University School of Public Health) that will set terms for how requests and access will be managed. We will ensure that a rigorous data governance structure is used by the data hosting service. The distribution will only occur with agreement from Principal Investigators and the investigators at all of the study sites.

Available IPD Datasets

Individual Participant Data Set (doi.org/10.5683/SP3/SIL)Access

Locations