The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001386224
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
17/08/2018
Date last updated
17/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
De-labelling patients with antibiotic allergy in Sydney adult and paediatric hospital allergy services - toward standardisation and improved patient outcomes
Scientific title
De-labelling patients with antibiotic allergy in Sydney adult and paediatric hospital allergy services - toward standardisation and improved patient outcomes.
Primary outcomes to be assessed are:
1. Proportion of patients assessed for penicillin allergy that are de-labelled.
2. Proportion of patients de-labelled who consider themselves (or their child) non-allergic to penicillin at follow up contact in 8 weeks.
Secondary ID [1] 295147 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Delabelling project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Penicillin allergy 308245 0
Condition category
Condition code
Inflammatory and Immune System 307405 307405 0 0
Allergies
Public Health 307454 307454 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Appropriate use of antibiotics is paramount in the era of multidrug resistant organisms and a dwindling new antibiotic pipeline. Data to guide the development of a safe, cost-effective and scalable antibiotic de-labelling strategy will improve health outcomes such as hospital length of stay, and reduce complications and costs associated with broad-spectrum antibiotics. We need to understand current practice, including variations in protocol, adherence to guidelines and resource requirements as a first step, then look to standardise prospective testing and de-labelling strategies.
This observational, prospective study will be conducted in two phases. Phase 1 (months 1-5) will describe current antibiotic de-labelling practice at participating sites and the outcomes. Phase 2 (months 7-11) will compare the same endpoints as phase 1 after the implementation of an evidence-based, standardised antibiotic de-labelling protocol.
It is anticipated that the standardised de-labelling protocol to be used in phase 2 of the study will be implemented following completion of this study.
Intervention code [1] 301583 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306377 0
Proportion of patients assessed for penicillin allergy that are de-labelled.
Patients undergoing penicillin allergy testing and/or challenge at a hospital specialist service will be consented to the study to allow for collection of information about the processes and outcomes of their penicillin allergy testing . This will be collected prospectively in the patients medical record (or a pre-printed data collection form) to be then entered into a Research electronic data capture system called REDCap.
Timepoint [1] 306377 0
Month 11
Primary outcome [2] 306378 0
Proportion of patients de-labelled who consider themselves (or their child) non-allergic to penicillin at follow up contact in 8 weeks.
Timepoint [2] 306378 0
8 week follow up
Secondary outcome [1] 348287 0
Adherence of testing to local (hospital) protocols in Phase 1.
This will be assessed by comparing data entered into REDCap versus data collection requirements of each hospitals standard of care testing protocol.
Timepoint [1] 348287 0
Month 5
Secondary outcome [2] 348288 0
Adherence of testing to standardised protocol in Phase 2.
This will be assessed by comparing data entered into REDCap versus data collection requirements of the phase 2 standardised protocol.
Timepoint [2] 348288 0
Month 11
Secondary outcome [3] 348292 0
Proportion of patients who received penicillin or alternate antibiotic between assessment and follow-up at 8 weeks.
This data will be collected by contacting the patient by telephone or email.
Timepoint [3] 348292 0
Week 8 Follow up

Eligibility
Key inclusion criteria
Any patient who requires assessment of penicillin allergy.
Willing and able to give written informed consent to participate in and comply with the study. (Or parent/guardian willing and able to give written informed consent if participant is a child).
We have ethics approval to enrol paediatrics and adults
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11184 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 11185 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 11186 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 11187 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [5] 11188 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [6] 11189 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 23030 0
2560 - Campbelltown
Recruitment postcode(s) [2] 23031 0
2170 - Liverpool
Recruitment postcode(s) [3] 23032 0
2031 - Randwick
Recruitment postcode(s) [4] 23033 0
2145 - Westmead
Recruitment postcode(s) [5] 23034 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299736 0
Other Collaborative groups
Name [1] 299736 0
The Sydney Partnership for Health, Education, Research & Enterprise (SPHERE)
Address [1] 299736 0
Level 4, Ingham Institute for Applied Medical Research,
1 Campbell St
Liverpool, NSW, 2170
Country [1] 299736 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst, NSW, 2010
Country
Australia
Secondary sponsor category [1] 299071 0
None
Name [1] 299071 0
Address [1] 299071 0
Country [1] 299071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300626 0
South Western Sydney Local Health District Human Research Ethics Committee [EC00136]
Ethics committee address [1] 300626 0
Locked Bag 7103 Liverpool BC NSW 1871
Ethics committee country [1] 300626 0
Australia
Date submitted for ethics approval [1] 300626 0
20/11/2017
Approval date [1] 300626 0
22/01/2018
Ethics approval number [1] 300626 0
HREC/17/LPOOL/490

Summary
Brief summary
AIMS: This research project aims to collect information about the processes and outcomes of antibiotic allergy testing in a standardised way in order to improve future quality of care and outcomes for people with antibiotic allergies. The focus of this project will be on individuals with penicillin allergy labels.
PARTICIPANTS: Patients who present to a hospital specialist service for assessment of penicillin allergy will be asked if they would like to participate.
METHODS: Collection of information that will be routinely collected at the patient's routine penicillin allergy assessment visit and a follow up telephone call or email 8 weeks after the visit. An optional blood sample may be collected on the day to store for future research related to drug allergy.
EXPECTED OUTCOMES: Improve access to antibiotic allergy delabelling
services, improve the way in which appropriate advice after delabelling
is provided to patients, and develop education resources for teaching and
implementation of best practice into other nonhospital settings. This will provide safer and more cost effective care for all.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84262 0
Dr Winnie Tong
Address 84262 0
St Vincent's Public Hospital,
IBAC, Level 4, Xavier
390 Victoria St
Darlinghurst, NSW, 2010
Country 84262 0
Australia
Phone 84262 0
+ 61 2 8382 2940
Fax 84262 0
Email 84262 0
winnie.tong@svha.org.au
Contact person for public queries
Name 84263 0
Ms Robyn Richardson
Address 84263 0
St Vincent's Public Hospital,
IBAC, Level 4, Xavier
390 Victoria St
Darlinghurst, NSW, 2010
Country 84263 0
Australia
Phone 84263 0
+ 61 2 8382 3872
Fax 84263 0
Email 84263 0
robyn.richardson@svha.org.au
Contact person for scientific queries
Name 84264 0
Dr Winnie Tong
Address 84264 0
St Vincent's Public Hospital,
IBAC, Level 4, Xavier
390 Victoria St
Darlinghurst, NSW, 2010
Country 84264 0
Australia
Phone 84264 0
+ 61 2 8382 2940
Fax 84264 0
Email 84264 0
winnie.tong@svha.org.au

No information has been provided regarding IPD availability
Summary results
No Results