HEMOFAST
Trial question
What is the role of multiplex PCR testing for the diagnosis of bloodstream infections?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 301
301 patients (104 female, 197 male).
Inclusion criteria: adult patients with suspected sepsis with positive blood culture confirmed by Gram stain.
Key exclusion criteria: hospitalization in a palliative care unit or with an estimated survival of < 1 month before sepsis; pregnancy; pediatric patients.
Interventions
N=148 multiplex PCR (blood culture identification panel [ePlex®] obtained according to Gram stain results of the first positive blood culture).
N=153 standard or care (matrix-assisted laser desorption/ionization time-of-flight mass spectrometry after overnight incubation and antimicrobial stewardship program).
Primary outcome
Proportion of patients with optimized treatment 12 hours after validation of first blood culture positivity and Gram stain result
82.4%
60.8%
82.4 %
61.8 %
41.2 %
20.6 %
0.0 %
Multiplex
PCR
Standard or
care
Significant
increase ▲
NNT = 4
Significant increase in the proportion of patients with optimized treatment 12 hours after validation of the first blood culture positivity and Gram stain result (82.4% vs. 60.8%; RR 1.36, 95% CI 0.32 to 2.4).
Secondary outcomes
No significant difference in death at day 30 (8.8% vs. 12.4%; RR 0.71, 95% CI -0.64 to 2.06).
Significantly shorter median time to obtain an optimized therapy (6.9 hours vs. 26.4 hours; AD -19.5 hours, 95% CI -31.07 to -7.93).
No significant difference in median length of stay (18 days vs. 20 days; AD -2 days, 95% CI -4.12 to 0.12).
Conclusion
In adult patients with suspected sepsis with positive blood culture confirmed by Gram stain, multiplex PCR was superior to standard or care with respect to proportion of patients with optimized treatment 12 hours after validation of the first blood culture positivity and Gram stain result.
Reference
Yvan Caspar, A Deves, C Richarme et al. Clinical impact and cost-consequence analysis of ePlex® blood culture identification panels for the rapid diagnosis of bloodstream infections: a single-center randomized controlled trial. Eur J Clin Microbiol Infect Dis. 2024 Mar 27.
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