ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

penicillin allergy

Condition category

Condition code

Inflammatory and Immune System

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]

Diagnosis / Prognosis

Comparator / control treatment

This is an uncontrolled study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Patient's will only be monitored for an hour after the dose.

Secondary outcome [1]

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]

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?

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Christchurch Hospital

Address [1]

Christchurch Hospital,
2 Riccarton Ave, Christchurch Central, Christchurch 8011

Country [1]

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]

Individual

Name [1]

Alan Pithie

Address [1]

Department of Infectious Diseases,
Christchurch Hospital,
2 Riccarton Avenue, Christchurch Central, 8011

Country [1]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Health and Disability Ethics Committe New Zealand

Ethics committee address [1]

Ministry of Health
 Health and Disability Ethics Committees
 PO Box 5013
 Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

12/09/2017

Approval date [1]

Ethics approval number [1]

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

Dr Heather Isenman

Address

Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011

Country

New Zealand

Phone

+64 3 364 0640

Fax

heather.isenman@cdhb.health.nz

Contact person for public queries

Name

Heather Isenman

Address

Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011

Country

New Zealand

Phone

+64 3 364 0640

Fax

heather.isenman@cdhb.health.nz

Contact person for scientific queries

Name

Heather Isenman

Address

Department of Infectious Diseases, 2 Riccarton Ave, Christchurch Central, Christchurch 8011

Country

New Zealand

Phone

+64 3 364 0640

Fax

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.

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