Trial Outcomes & Findings for Paediatric Rapid Sepsis Trigger (PRST) Tool (NCT NCT04304235)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18693 participants

Primary outcome timeframe

1 day

Results posted on

2025-05-13

Participant Flow

Recruitment occurred at hospitals in two countries . Each country had a control and intervention site. A baseline period of data collection occurred at all sites except the control site in Uganda (due to COVID 19 pandemic restrictions). Kenya: Intervention site Baseline, Kenya Intervention site Implementation, Kenya Control site Baseline, Kenya Control site Implementation Uganda: Intervention site Baseline, Uganda Intervention site Implementation, Uganda Control site Implementation:

Non infectious illness, routine clinic visit

Participant milestones

Participant milestones
Measure	Kenya Intervention Baseline 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.	Kenya Intervention Implementation Hospital nurses will triage participants using the digital triage tool (mhealth intervention). Pediatric Rapid Sepsis Trigger (PRST) tool: 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 Control Baseline 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.	Kenya Control Implementation 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.	Uganda Intervention Baseline 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.	Uganda Intervention Implementation Hospital nurses will triage participants using the digital triage tool (mhealth intervention). Pediatric Rapid Sepsis Trigger (PRST) tool: 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.	Uganda Control Implementation 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.
Overall Study STARTED	2856	3497	2520	3177	1697	2026	2920
Overall Study COMPLETED	2856	3428	2520	3177	1408	1903	2855
Overall Study NOT COMPLETED	0	69	0	0	289	123	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Kenya Intervention Baseline 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.	Kenya Intervention Implementation Hospital nurses will triage participants using the digital triage tool (mhealth intervention). Pediatric Rapid Sepsis Trigger (PRST) tool: 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 Control Baseline 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.	Kenya Control Implementation 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.	Uganda Intervention Baseline 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.	Uganda Intervention Implementation Hospital nurses will triage participants using the digital triage tool (mhealth intervention). Pediatric Rapid Sepsis Trigger (PRST) tool: 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.	Uganda Control Implementation 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.
Overall Study incomplete triage data	0	69	0	0	289	123	65

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kenya Intervention Baseline n=2856 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=3428 Participants Implementation cohort at Kenya implementation site	Kenya Control Baseline n=2520 Participants Baseline cohort at Kenya control site	Kenya Control Implementation n=3177 Participants Implementation cohort at Kenya control site	Uganda Intervention Baseline n=1408 Participants Baseline cohort at Uganda intervention site	Uganda Intervention Implementation n=1903 Participants Implementation cohort at Uganda implementation site	Uganda Control Implementation n=2855 Participants Implementation cohort at Uganda control site	Total n=18147 Participants Total of all reporting groups
Age, Continuous	25 Months n=2856 Participants	31.2 Months n=3428 Participants	17.55 Months n=2520 Participants	13.3 Months n=3177 Participants	13.55 Months n=1408 Participants	15 Months n=1903 Participants	17.3 Months n=2855 Participants	22.4 Months n=18147 Participants
Sex: Female, Male Female	1252 Participants n=2856 Participants	1466 Participants n=3428 Participants	1207 Participants n=2520 Participants	1504 Participants n=3177 Participants	676 Participants n=1408 Participants	908 Participants n=1903 Participants	1418 Participants n=2855 Participants	8431 Participants n=18147 Participants
Sex: Female, Male Male	1604 Participants n=2856 Participants	1962 Participants n=3428 Participants	1313 Participants n=2520 Participants	1673 Participants n=3177 Participants	732 Participants n=1408 Participants	995 Participants n=1903 Participants	1437 Participants n=2855 Participants	9716 Participants n=18147 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Time to antimicrobial administration	115 Minutes n=2856 Participants	123 Minutes n=3428 Participants	239 Minutes n=2520 Participants	261 Minutes n=3177 Participants	255 Minutes n=1408 Participants	239 Minutes n=1903 Participants	212 Minutes n=2855 Participants	206 Minutes n=18147 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Children presenting to the outpatient department at facility

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.

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=2856 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=3428 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=2520 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation n=3177 Participants Implementation cohort at the Kenya control site	Uganda Intervention Baseline n=1408 Participants Baseline cohort at Uganda intervention site	Uganda Intervention Implementation n=1903 Participants Implementation cohort at the Uganda intervention site	Uganda Control Implementation n=2855 Participants Implementation cohort at Uganda control site
Time to Administration of an Appropriate Antimicrobial	115 minutes Interval 68.0 to 203.0	123 minutes Interval 68.0 to 213.0	239 minutes Interval 160.0 to 388.0	261 minutes Interval 193.0 to 392.0	255 minutes Interval 186.0 to 348.0	239 minutes Interval 171.0 to 303.0	212 minutes Interval 129.0 to 295.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: All participants

The child is readmitted to the hospital after being discharged

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=4264 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=8552 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=5331 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation Implementation cohort at the Kenya control site	Uganda Intervention Baseline Baseline cohort at Uganda intervention site	Uganda Intervention Implementation Implementation cohort at the Uganda intervention site	Uganda Control Implementation Implementation cohort at Uganda control site
Readmission	57 Participants	57 Participants	48 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Population: All participants

Death within 7 days

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=4264 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=8552 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=5331 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation Implementation cohort at the Kenya control site	Uganda Intervention Baseline Baseline cohort at Uganda intervention site	Uganda Intervention Implementation Implementation cohort at the Uganda intervention site	Uganda Control Implementation Implementation cohort at Uganda control site
Mortality	39 Participants	23 Participants	14 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours

Population: All enrolled children

Admission to hospital

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=4264 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=8552 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=5331 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation Implementation cohort at the Kenya control site	Uganda Intervention Baseline Baseline cohort at Uganda intervention site	Uganda Intervention Implementation Implementation cohort at the Uganda intervention site	Uganda Control Implementation Implementation cohort at Uganda control site
Admission	581 Participants	474 Participants	452 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 hours

Population: All participants.

The clinical diagnosis for each participant

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=567 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=472 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=451 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation Implementation cohort at the Kenya control site	Uganda Intervention Baseline Baseline cohort at Uganda intervention site	Uganda Intervention Implementation Implementation cohort at the Uganda intervention site	Uganda Control Implementation Implementation cohort at Uganda control site
Clinical Diagnosis Other	161 Participants	123 Participants	123 Participants	—	—	—	—
Clinical Diagnosis Malaria	131 Participants	100 Participants	85 Participants	—	—	—	—
Clinical Diagnosis Pneumonia	139 Participants	154 Participants	104 Participants	—	—	—	—
Clinical Diagnosis Broncholitis	3 Participants	5 Participants	2 Participants	—	—	—	—
Clinical Diagnosis Diarrhea/ Gastro	15 Participants	12 Participants	12 Participants	—	—	—	—
Clinical Diagnosis Meningitis	11 Participants	6 Participants	5 Participants	—	—	—	—
Clinical Diagnosis Malnutrition	17 Participants	5 Participants	8 Participants	—	—	—	—
Clinical Diagnosis Septicemia	58 Participants	23 Participants	75 Participants	—	—	—	—
Clinical Diagnosis Neonatal sepsis	12 Participants	32 Participants	17 Participants	—	—	—	—
Clinical Diagnosis Dehydration	20 Participants	12 Participants	20 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Length of stay in hospital for admitted cases

Outcome measures

Outcome measures
Measure	Kenya Intervention Baseline n=581 Participants Baseline cohort at Kenya intervention site	Kenya Intervention Implementation n=474 Participants Implementation cohort at the Kenya intervention site	Kenya Control Baseline n=452 Participants Baseline cohort at the Kenya control site	Kenya Control Implementation Implementation cohort at the Kenya control site	Uganda Intervention Baseline Baseline cohort at Uganda intervention site	Uganda Intervention Implementation Implementation cohort at the Uganda intervention site	Uganda Control Implementation Implementation cohort at Uganda control site
Length of Stay	4 Days Interval 2.0 to 7.0	4 Days Interval 3.0 to 6.0	4 Days Interval 2.0 to 6.0	—	—	—	—

POST_HOC outcome

Timeframe: 24 hours

Population: Participants admitted to hospital

Number cases receiving antimicrobials in the cohort of admitted cases