Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001342303p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2017
Date registered
22/09/2017
Date last updated
22/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing low risk penicillin allergic hospital patients with a single dose of oral amoxicillin
Scientific title
Safety of direct oral amoxicillin challenge study of penicillin allergic general medical hospital inpatients.
Secondary ID [1] 292867 0
nil known
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
penicillin allergy 304713 0
Condition category
Condition code
Inflammatory and Immune System 304021 304021 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299110 0
Diagnosis / Prognosis
Comparator / control treatment
This is an uncontrolled study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303355 0
Safety of direct oral amoxicillin challenge of low risk hospital inpatients - patients will be clinically monitored for one hour after their dose of amoxicillin. Clinical outcomes which will be monitored for include rash, change in blood pressure (measured with sphygmomanometer) or heart rate (pulse oximeter), breathing difficulties or wheeze, facial swelling, and any other symptoms patient's report.
Timepoint [1] 303355 0
Patient's will only be monitored for an hour after the dose.
Secondary outcome [1] 338732 0
feasibility of penicillin allergy testing in the acute hospital inpatient setting - this will be monitored in terms of ease of recruiting patients, and administering test amoxicillin doses during a patient's general medical admission, without obstructing their normal care. The outcome will be assessed by means of interviews with medical staff.
Timepoint [1] 338732 0
At end of study - ideally after 100 patients recruited

Eligibility
Key inclusion criteria
Patient's admitted to the general medical service of Christchurch Hospital with recorded penicillin allergy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
As this is an intitial safety/feasibility study, we are aiming to recruit roughly 100 patients, We will then expand the study across our institution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2017
Actual
Date of last participant enrolment
Anticipated
5/03/2018
Actual
Date of last data collection
Anticipated
9/03/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 9202 0
New Zealand
State/province [1] 9202 0
Canterbury

Funding & Sponsors
Funding source category [1] 297496 0
Hospital
Name [1] 297496 0
Christchurch Hospital
Country [1] 297496 0
New Zealand
Primary sponsor type
Individual
Name
Heather Isenman
Address
Department of Infectious Diseases,
Christchurch Hospital,
2 Riccarton Avenue, Christchurch Central, 8011
Country
New Zealand
Secondary sponsor category [1] 296501 0
Individual
Name [1] 296501 0
Alan Pithie
Address [1] 296501 0
Department of Infectious Diseases,
Christchurch Hospital,
2 Riccarton Avenue, Christchurch Central, 8011
Country [1] 296501 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298596 0
Health and Disability Ethics Committe New Zealand
Ethics committee address [1] 298596 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298596 0
New Zealand
Date submitted for ethics approval [1] 298596 0
12/09/2017
Approval date [1] 298596 0
Ethics approval number [1] 298596 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77602 0
Dr Heather Isenman
Address 77602 0
Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011
Country 77602 0
New Zealand
Phone 77602 0
+64 3 364 0640
Fax 77602 0
Email 77602 0
heather.isenman@cdhb.health.nz
Contact person for public queries
Name 77603 0
Dr Heather Isenman
Address 77603 0
Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011
Country 77603 0
New Zealand
Phone 77603 0
+64 3 364 0640
Fax 77603 0
Email 77603 0
heather.isenman@cdhb.health.nz
Contact person for scientific queries
Name 77604 0
Dr Heather Isenman
Address 77604 0
Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011
Country 77604 0
New Zealand
Phone 77604 0
+64 3 364 0640
Fax 77604 0
Email 77604 0
heather.isenman@cdhb.health.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.