NCT04304235: PRST

Paediatric Rapid Sepsis Trigger (PRST) Tool

Completed NA Results posted Last updated 13 May 2025

What this trial tests

NA trial testing Pediatric Rapid Sepsis Trigger (PRST) tool in Sepsis in 18,693 participants. Completed in 1 July 2023.

Timeline

27 April 2020

Primary endpoint
1 July 2023

1 July 2023

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	18,693
Start date	27 April 2020
Primary completion	1 July 2023
Estimated completion	1 July 2023
Sites	3 locations across Kenya, Uganda

Drugs / interventions tested

• Pediatric Rapid Sepsis Trigger (PRST) tool
• Emergency Triage and Treatment (ETAT) guidelines

Conditions studied

• Sepsis — all drugs for Sepsis →
• Infection — all drugs for Infection →

Sponsor

University of British Columbia

Who can join

Under 19, any sex, with Sepsis or Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Administration of an Appropriate Antimicrobial Primary · 1 day

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.

Group	Value	95% CI
Kenya Intervention Baseline	115	68 – 203
Kenya Intervention Implementation	123	68 – 213
Kenya Control Baseline	239	160 – 388
Kenya Control Implementation	261	193 – 392
Uganda Intervention Baseline	255	186 – 348
Uganda Intervention Implementation	239	171 – 303
Uganda Control Implementation	212	129 – 295

Readmission Secondary · 7 days

The child is readmitted to the hospital after being discharged

Group	Value	95% CI
Baseline Sites	57
Control Sites	57
Intervention Sites	48

Mortality Secondary · 7 days

Death within 7 days

Group	Value	95% CI
Baseline Sites	39
Control Sites	23
Intervention Sites	14

Admission Secondary · 12 hours

Admission to hospital

Group	Value	95% CI
Baseline Sites	581
Control Sites	474
Intervention Sites	452

Clinical Diagnosis Secondary · 12 hours

The clinical diagnosis for each participant

Group	Value	95% CI
Baseline Sites	131
Control Sites	100
Intervention Sites	85
Baseline Sites	139
Control Sites	154
Intervention Sites	104
Baseline Sites	3
Control Sites	5
Intervention Sites	2
Baseline Sites	15
Control Sites	12
Intervention Sites	12

Length of Stay Secondary · 7 days

Length of stay in hospital for admitted cases

Group	Value	95% CI
Baseline Sites	4	2 – 7
Control Sites	4	3 – 6
Intervention Sites	4	2 – 6

Number of Intravenous Antimicrobials in Admitted Cases Secondary · 24 hours

Number cases receiving antimicrobials in the cohort of admitted cases

Group	Value	95% CI
Baseline Sites	512
Control Sites	361
Intervention Sites	406

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Smart triage: triage and management of sepsis in children using the point-of-care Pediatric Rapid Sepsis Trigger (PRST) tool.
   Mawji A, Li E, Komugisha C, Akech S, et al · · 2020 · cited 30× · PMID 32493319 · DOI 10.1186/s12913-020-05344-w
2. Smart triage: Development of a rapid pediatric triage algorithm for use in low-and-middle income countries.
   Mawji A, Li E, Dunsmuir D, Komugisha C, et al · · 2022 · cited 16× · PMID 36483471 · DOI 10.3389/fped.2022.976870
3. Health worker perspectives of Smart Triage, a digital triaging platform for quality improvement at a referral hospital in Uganda: a qualitative analysis.
   Novakowski SK, Kabajaasi O, Kinshella MW, Pillay Y, et al · · 2022 · cited 14× · PMID 36229790 · DOI 10.1186/s12887-022-03627-1
4. Cost-effectiveness analysis of Smart Triage, a data-driven pediatric sepsis triage platform in Eastern Uganda.
   Li ECK, Tagoola A, Komugisha C, Nabweteme AM, et al · · 2023 · cited 7× · PMID 37653477 · DOI 10.1186/s12913-023-09977-5
5. External validation of a paediatric Smart triage model for use in resource limited facilities.
   Kigo J, Kamau S, Mawji A, Mwaniki P, et al · · 2024 · cited 4× · PMID 38905166 · DOI 10.1371/journal.pdig.0000293
6. Repeatability of Pulse Oximetry Measurements in Children During Triage in 2 Ugandan Hospitals.
   Asdo A, Mawji A, Agaba C, Komugisha C, et al · · 2023 · cited 4× · PMID 37640488 · DOI 10.9745/ghsp-d-22-00544
7. Repeatability of RRate measurements in children during triage in two Ugandan hospitals.
   Asdo A, Mawji A, Omara I, Aye Ishebukara IA, et al · · 2025 · cited 3× · PMID 39775211 · DOI 10.1371/journal.pgph.0003097
8. Cost-effectiveness analysis protocol of the Smart Triage program: A point-of-care digital triage platform for pediatric sepsis in Eastern Uganda.
   Li ECK, Grays S, Tagoola A, Komugisha C, et al · · 2021 · cited 3× · PMID 34788338 · DOI 10.1371/journal.pone.0260044