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Testing low risk penicillin allergic hospital patients with a single dose of oral amoxicillin

Safety of direct oral amoxicillin challenge study of penicillin allergic general medical hospital inpatients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001342303
Acronym
NA
Enrollment
100
Registered
2017-09-22
Start date
2017-11-06
Completion date
2018-03-05
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Penicillin allergy is reported by between 10 and 20% of hospital inpatients, However, fewer than 10% of these patients have allergy confirmed on formal testing. Being labelled as penicillin allergic carries a substantial burden. There is increased length of stay, cost, and adverse outcomes associated with penicillin allergy, a need for alternative antimicrobial agents, and potential for treatment failure and readmission. Accordingly, the recent Infectious Diseases Society of America (IDSA) antimicrobial stewardship guidelines recommend reviewing patient’s antibiotic allergy status as an integral stewardship intervention. An immediate hypersensitivity or IgE mediated reaction is normally excluded by skin testing, followed by an oral challenge, as recommended by the Australasian Society of Clinical Immunology and Allergy (ASCIA). Skin testing requires: (i) specific reagents, some of which are in short supply, and (ii) expertise and manpower to execute, and is thus not always feasible in a busy hospital setting. Skin tests are positive in between 0.8% and 4% and of patients. Of patients with a negative skin test given an oral challenge, only 0.8% to 1.5% of patients experience reactions, typically cutaneous rather than anaphylactic. A recent study challenged 328 low risk penicillin allergic outpatients with a single dose of oral amoxicillin, without prior skin testing. There were only 5 (1.5%) cutaneous reactions, with no episodes of anaphylaxis. There have been no studies assessing direct oral challenge of hospital inpatients, but successful approaches utilising skin testing to determine allergy status in hospital inpatients. Based on this data and the low rate of 'true' allergy in the form of immediate hypersensitivity amongst reportedly penicillin allergic patients, we feel that it should be feasible to administer an oral challenge to carefully selected low risk hospital inpatients. The ASCIA guidelines suggest that in cases where the clinical history does not suggest an IgE mediated allergy, skin testing is not required, and a direct oral challenge may be given. This will enable a more proactive, real time stewardship intervention than skin testing, which is often delayed to the outpatient setting.

Interventions

Carefully selected patients with penicillin allergy who are deemed at low risk of immediate hypersensitivity reaction will be given a test oral dose of amoxicillin 250mg capsule and monitored for reaction. This is a safety and feasibility study.

Sponsors

Heather Isenman
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient's admitted to the general medical service of Christchurch Hospital with recorded penicillin allergy

Exclusion criteria

Previous allergic reaction within 1 hour of administration of penicillin (urticaria, angioedema, bronchospasm, anaphylaxis). Previous severe cutaneous drug reaction (blistering) following penicillin Delayed reaction with mucosal, systemic or organ involvement following penicillin End of life/actively dying Haemoydnamically unstable Physiological frailty (physician discretion) Serum sickness reaction Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026