Individualised, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia (REGARD-VAP): a multicentre, individually randomised, open-label, non-inferiority trial
Primary resultResult — go to the resultRisk difference −3% one-sided 95% CI -∞ to 5%Authors' conclusion
In this study of adults with VAP, individualised shortened antibiotic duration guided by clinical response was non-inferior to longer treatment durations in terms of 60-day mortality and pneumonia recurrence, and associated with substantially reduced antibiotic use and side-effects.
Study context
- Population
- Adults with ventilator-associated pneumonia (VAP) (CDC NHSN criteria), mechanically ventilated ≥48 h, on culture-directed antibiotics, after fever resolution for 48 h and haemodynamic stability; 39 ICUs in Nepal, Singapore, Thailand460 ITT analysed
- Participants
- 461 adults
- Comparison
- Individualised short-course vs usual long-course antibiotic treatment
- Short-coursen = 232
- Usual caren = 229reference
- Primary endpoint
- Composite of:
- Death
- Pneumonia recurrence
- Follow-up
- 60 days
Methodological detailsphase 4, multicentre, individually randomised, open-label, hierarchical non-inferiority-superiority, masked outcome assessment, Enrolled May 25, 2018, to Dec 16, 2022, Assessors for recurrent pneumonia and participants masked; clinicians not
- Phase 4
- Multicentre
- Individually randomised
- Open-label
- Hierarchical non-inferiority-superiority
- Masked outcome assessment
- Enrolled May 25, 2018, to Dec 16, 2022
- Assessors for recurrent pneumonia and participants masked; clinicians not
Primary result
As reported in the abstract
Risk difference
−3%
one-sided 95% CI -∞ to 5%
Events by treatment group
Short-course vs Usual care
risk difference −3% (one-sided 95% CI -∞ to 5%)
Non-inferiority margin 12 as printed, not drawn
Further findings
Antibiotic treatment duration for index VAP episode
Safety
| Outcome | Short-course | Usual care | Risk difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Antibiotic side-effects (per-protocol population) | 8% | 38% | −31% (−37 to −25%) | P < 0.0001 | |
| −40−20020Difference (linear scale) |
- Antibiotic side-effects (per-protocol population): per-protocol: 211 short-course, 224 usual care
Original publication
Individualised, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia (REGARD-VAP): a multicentre, individually randomised, open-label, non-inferiority trial. Lancet Respir Med. Published 22 January 2024. doi:10.
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