ADAPT-Sepsis (procalcitonin-guided)
Trial question
What is the role of procalcitonin-guided antibiotic duration in hospitalized patients with suspected sepsis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 1836
1836 patients (729 female, 1107 male).
Inclusion criteria: hospitalized critically ill adults who have been commenced on intravenous antibiotics for sepsis.
Key exclusion criteria: requirement of prolonged antibiotic therapy; severe immunocompromised state from a cause other than sepsis; expected to receive IL-6 receptor inhibitors during acute hospital admission; sepsis treatments likely to stop within 24 hours because of futility.
Interventions
N=918 daily PCT-guided protocol (daily serum procalcitonin measurement until antibiotic discontinuation plus standard care).
N=918 standard care (no procalcitonin testing).
Primary outcome
Total antibiotic treatment duration to 28 days
9.8 days
10.7 days
10.7 days
8.0 days
5.3 days
2.7 days
0.0 days
Daily PCT-guided
protocol
Standard
care
Significant
decrease ▼
Significant decrease in total antibiotic treatment duration to 28 days (9.8 days vs. 10.7 days; MD -0.88, 95% CI -1.58 to -0.19).
Secondary outcomes
Significant decrease in antibiotic treatment duration for initial sepsis period (7 days vs. 8.1 days; MD -1.13, 95% CI -1.68 to -0.58).
No significant difference in ≥ 1 event of unscheduled care escalation or readmission (23.4% vs. 26.2%; ARD -2.8, 95% CI -6.76 to 1.16).
No significant difference in death at day 90 (25.6% vs. 25.5%; AD 0.09%, 95% CI -4.08 to 4.29).
Safety outcomes
No significant differences in death at day 28, serious adverse events.
Conclusion
In hospitalized critically ill adults who have been commenced on intravenous antibiotics for sepsis, daily PCT-guided protocol was superior to standard care with respect to total antibiotic treatment duration to 28 days.
Reference
Paul Dark, Anower Hossain, Daniel F McAuley et al. Biomarker-Guided Antibiotic Duration for Hospitalized Patients With Suspected Sepsis: The ADAPT-Sepsis Randomized Clinical Trial. JAMA. 2024 Dec 9. Online ahead of print.
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