An interventional study of Direct oral penicillin challenge and Standard of care in Hypersensitivity, Immediate, Hypersensitivity, Delayed and Hypersensitivity Response, sponsored by Austin Health. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by Austin Health · Not applicable, Interventional, and Diagnostic
Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.
Patient-reported penicillin allergies result in poor health outcomes for patients and drive inappropriate antibiotic prescribing, antimicrobial resistance and healthcare costs. Our group has internally and externally validated a novel penicillin allergy clinician decision rule (PEN-FAST) that is able to identify low risk penicillin allergies with a negative predictive value of 96% (95%; 94-98%). Therefore, whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's enrollment of 382 is above the median of 70 across 66 interventional studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →Austin Health is the lead sponsor of 42 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Direct oral antibiotic (penicillin) challenge in patients with PEN-Fast less than 3.
Other: Direct oral penicillin challenge
Standard of care: skin testing and, if negative, oral challenge.
Other: Standard of care
The patient will receive a single dose of oral penicillin, following baseline vital signs.
Routine management as per the treating clinicians that include skin prick and intradermal beta-lactam testing, followed by oral penicillin challenge in the setting of negative skin testing.
The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)
Time frame: up to 48H after oral challenge
Proportion of patients referred to the outpatient allergy clinic that are eligible for intervention (i.e randomization) as per protocol [Eligibility to screened ratio]
Time frame: Before randomization
Feasibility of recruitment defined as the proportion of patients consenting to participate in the study as per protocol from eligible patients. [Recruitment to eligibility ratio].
Time frame: Before randomization
Feasibility of intervention delivery defined as the proportion of patients randomized to the intervention arm who had the intervention delivered as per protocol. [Intervention to recruitment ratio]
Time frame: Before randomization
The proportion of patients with a penicillin allergy who experience an antibiotic associated immune mediated adverse event OR severe adverse drug reaction as per protocol definitions.
Time frame: Up to 48h after the drug challenge
The proportion of patients with a penicillin allergy who experience an antibiotic associated non-immune mediated adverse event.
Time frame: Up to 48h after the drug challenge
The proportion of patients that will respect the protocol (protocol compliance)
Time frame: Up to 48h after the drug challenge
Proportion of patient with positive Penicillin Skin Testing
Time frame: Up to 48h after the drug challenge
Proportion of patients with non-immune mediated positive oral provocation
Time frame: Up to 48h after the drug challenge
Proportion of patients with severe adverse reaction - anaphylaxis/death
Time frame: Up to 48h after the drug challenge
Time from randomization to delabelling
Time frame: Up to 48h after the drug challenge
Number of appointments required for Penicillin delabelling
Time frame: Up to 48h after the drug challenge
Assessment with the Pre-Questionnaire and the 6 months follow-up Questionnaire
Time frame: Up to 6 months after the drug challenge
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Dec 2022, 17 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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