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

Austin Health0 个研究点目标入组 80 人开始时间: 2021年1月20日最近更新: 2024年1月29日

适应症

试验速览

暂无简介。

•1.A low or moderate penicillin allergy phenotype with a PEN-FAST score < 3
•2.Are expected to stay in the ICU at least 24 hours from time of initial assessment

•1.Patient age is < 18 years
•2.Pregnancy
•3.DNR (do not resuscitate) DNI (do not intubate) orders
•4.Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
•5.Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with subject’s participation in this study
•6.Patients with known history of drug-associated anaphylaxis
•7.Patients with idiopathic urticaria/anaphylaxis or mastocytosis
•8.Patients where the allergy history was not able to be confirmed with patient or substitute decision maker
•9.Patients on antihistamine therapy (excluding ranitidine)
•10.Patients on adrenaline or noradrenaline therapy in last 4 hours
•11.Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone [or steroid equivalent])
•12.High ventilator requirement if intubated (any of the following)
•i.Any mode other than spontaneous
•ii.Peak end expiratory pressure (PEEP) >5cm H2O
•iii.FiO2 >40%

发起方