INHALE WP3
Trial question
What is the role of rapid in-ICU syndromic PCR testing for pathogens in patients with hospital-acquired pneumonia or ventilator-associated pneumonia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 545
545 patients (172 female, 373 male).
Inclusion criteria: adults and children with suspected hospital-acquired pneumonia or ventilator-associated pneumonia.
Key exclusion criteria: previous participation in the trial; participation in another interventional trial; moribund and/or not expected to live > 48 hours; existing directive to withhold life-sustaining treatment.
Interventions
N=276 rapid in-ICU syndromic PCR (portion of the sample tested as quickly as possible using the FilmArray® Torch Pneumonia Panel Plus platform while the remainder underwent standard testing).
N=269 standard of care (portion of each sample frozen at < -20°C within 24 hours, whilst the remainder underwent standard testing).
Primary outcome
Successful antibiotic stewardship at 24 hours post-randomization
76.5%
55.9%
76.5 %
57.4 %
38.3 %
19.1 %
0.0 %
Rapid in-ICU syndromic
PCR
Standard of
care
Significant
increase ▲
NNT = 4
Significant increase in successful antibiotic stewardship at 24 hours post-randomization (76.5% vs. 55.9%; OR 2.57, 95% CI 1.77 to 3.73).
Secondary outcomes
Borderline significant decrease in clinical cure at 14 days (56.7% vs. 64.5%; OR 0.68, 95% CI 0.47 to 0.98).
No significant difference in death at day 28 (31.3% vs. 28.2%; HR 1.18, 95% CI 0.87 to 1.61).
No significant difference in ICU length of stay (11 days vs. 13 days; HR 0.95, 95% CI 0.82 to 1.1).
Safety outcomes
No significant differences in septic shock, C. difficile infection, and secondary pneumonia within 21 days of randomization.
Conclusion
In adults and children with suspected hospital-acquired pneumonia or ventilator-associated pneumonia, rapid in-ICU syndromic PCR was superior to standard of care with respect to successful antibiotic stewardship at 24 hours post-randomization.
Reference
Virve I Enne, Susan Stirling, Julie A Barber et al. INHALE WP3, a multicentre, open-label, pragmatic randomised controlled trial assessing the impact of rapid, ICU-based, syndromic PCR, versus standard-of-care on antibiotic stewardship and clinical outcomes in hospital-acquired and ventilator-associated pneumonia. Intensive Care Med. 2025 Feb;51(2):272-286.
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