N/A
Completed N=18,693
Paediatric Rapid Sepsis Trigger (PRST) Tool
Source: ClinicalTrials.gov NCT04304235 ↗Enrolled (actual)
18,693
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Time to Administration of an Appropriate Antimicrobial — 115; 123; 239; 261 minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Administration of an Appropriate Antimicrobial |
115; 123; 239; 261; 255; 239 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
-Patients presenting to the outpatient department for elective cases (e.g. elective surgery or change of dressing) or for clinical review appointment.
Data sourced from ClinicalTrials.gov (NCT04304235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.