Table 2 ORACLE study eligibility criteria

Inclusion criteria

 1. Adult (≥ 18 years) ICU inpatient

 2. Reported penicillin allergy with a PEN-FAST score < 3

 3. Are expected to stay in the ICU at least 24 h post-assessment

Exclusion criteria (patient excluded if ONE of the following criteria present)

 1. Known pregnancy

 2. Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or medical treatment decision-maker is not committed to active treatment

 3. Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with subject’s participation in this study

 4. Patients with known history of ANY non-penicillin drug-associated anaphylaxis

 5. Patients with a known history of idiopathic urticaria, idiopathic anaphylaxis or mastocytosis

 6. Patients where the allergy history was not able to be confirmed with patient or medical treatment decision-maker

 7. Patients on antihistamine therapy (excluding H2-receptor antagonists)

 8. Patients receiving > 10 µg/minute of noradrenaline or any adrenaline therapy in the last 4 h

 9. High ventilator requirement if intubated (any of the following)

  i. Any mode other than spontaneous

  ii. Peak end-expiratory pressure (PEEP) > 5 cm H2O

  iii. FiO2 > 40%

 10. Patients receiving more than stress dose steroid therapy (i.e. > 50 mg QID hydrocortisone or daily equivalent)