Procalcitonin testing combined with NEWS2 evaluation compared with usual care based on NEWS2 for identification of sepsis and antibiotic initiation in the emergency department in England and Wales (PRONTO): a multicentre, randomised, controlled, open-label, phase 3 trial
An erratum to this article was published (Lancet Respir Med, May 2026 ↗)
Authors' conclusion
Making a procalcitonin-guided algorithm available to clinicians in emergency departments did not change intravenous antibiotic initiation at 3 h in patients managed as suspected sepsis, but a decrease in 28-day mortality was seen
Study context
- Population
- Patients aged ≥16 years with suspected sepsis in 20 ED in England and Wales5,453 in primary analysis
- Participants
- 7,667 patients
- Comparison
- Procalcitonin-guided care vs usual care
- Procalcitonin-guided caren = 3,831
- Usual caren = 3,836reference
- Primary endpoint
- Co-primary: IV antibiotic initiation at 3 h (superiority) and 28-day mortality (non-inferiority, margin 2.5% risk difference) from triage
- Follow-up
- 3 h; 28 days
Methodological detailsphase 3, multicentre, open-label, parallel two-arm, individually randomised, co-primary endpoints: superiority and non-inferiority
- Phase 3
- Multicentre
- Open-label
- Parallel two-arm
- Individually randomised
- Co-primary endpoints: superiority and non-inferiority
Primary result
As reported in the abstract
IV antibiotic initiation at 3 h; 28-day mortality
Procalcitonin-guided care vs Usual careEstimateP value
IV antibiotic initiation at 3 h
adjusted risk difference −0.08 percentage points(95% CI −2.58 to 2.42)
P = 0.9528-day mortality
adjusted risk difference −3.12 percentage points(90% CI −4.68 to −1.57)
P = 0.0009Non-inferiority margin 2.5 as printed, not drawn
Further findings
| Outcome | Procalcitonin-guided care |
|---|---|
| Procalcitonin result considered in clinical decision making | 64.7% |
Planned subgroup, sensitivity and secondary analyses
- Improved mortality not explained by these analyses
Safety
Adverse events (180 total)
Events Usual care 96 · Procalcitonin-guided care 84
Participants Usual care 2968 · Procalcitonin-guided care 3042
| Outcome | Usual care | Procalcitonin-guided care |
|---|---|---|
| Serious adverse event probably or definitely attributable to procalcitonin test | <1% | |
| Participants | — not stated in the abstract | 2042 |
— not stated in the abstract
Original publication
Procalcitonin testing combined with NEWS2 evaluation compared with usual care based on NEWS2 for identification of sepsis and antibiotic initiation in the emergency department in England and Wales (PRONTO): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Respir Med. Published 22 March 2026. doi:10.
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