ICU sedation, delirium & recovery
Oral challenge vs routine care to assess low-risk penicillin allergy in critically ill hospital patients (ORACLE): a pilot safety and feasibility randomised controlled trial
Authors' conclusion
These findings support the safety, validity, and feasibility of direct enteral challenge for critically ill patients with PEN-FAST assessed low-risk penicillin allergy.
Study context
- Population
- Critically ill ICU patients with a low-risk penicillin allergy label (PEN-FAST score < 3), four intensive care units (ICUs), Melbourne, Australia533 screened
- Participants
- 80 patients
- Comparison
- Direct enteral penicillin challenge vs routine care
- Direct enteral challengen = 40
Methodological detailspilot, safety and feasibility, multicentre (four ICUs), 1:1 randomisation, Patients reviewed at 24 h and 5 days after each challenge/observation
- Pilot
- Safety and feasibility
- Multicentre (four ICUs)
- 1:1 randomisation
- Patients reviewed at 24 h and 5 days after each challenge/observation
Primary result
As reported in the abstract
Positive direct enteral challenge rate
Positive challenge rate with direct enteral challenge
2.5%
Further findings
Repeat challenge post-ICU (intervention arm)
- Received a repeat challenge
- 32/40 (80%)
- Positive repeat challenges
- 0
Penicillin received post-randomisation
- Intervention arm received penicillin
- 13 (32%)
- Control arm received penicillin
- 4 (10%)
- Intervention vs control, OR [p = 0.019]
- 4.33 [1.27, 14.78]
Safety
Antibiotic-associated serious adverse events
- None identified
- 0
Original publication
Oral challenge vs routine care to assess low-risk penicillin allergy in critically ill hospital patients (ORACLE): a pilot safety and feasibility randomised controlled trial. Intensive Care Med. Published 13 May 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →