The safety and feasibility of an oral test-dose challenge to assess low-risk penicillin allergy in critically ill hospital patients.

Not Applicable

Active, not recruiting

• Conditions: Penicillin allergy; Inflammatory and Immune System - Allergies; Antibiotic-associated adverse events; Infection - Other infectious diseases

• Registration Number: ACTRN12621000051842
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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%

Study & Design

• Study Type: Interventional
• Study Design: Not specified