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Allergy Antibiotics And Microbial Resistance (ALABAMA)

Primary Purpose

Infection

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
penicillin allergy assessment pathway
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infection focused on measuring penicillin, allergy, antimicrobial, resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or Female, aged 18 years or above
  • Current penicillin allergy (or sensitivity) record of any kind in their electronic health record
  • Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months

N.B. Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary.

Exclusion Criteria:

  • Life expectancy estimated <1 year by GP

    • Unable to attend immunology clinic

    • Unsuitable for entry into testing pathway because:

      • Allergy history consistent with anaphylaxis to penicillin
      • History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin
      • Previous specialist investigation for penicillin allergy
      • History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions
      • Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle
    • Pregnant
    • Breastfeeding mothers
    • Taking beta blocker medication
    • Currently receiving or due to start immunosuppressive medication
    • Currently taking (or recently taken) systemic steroids and unable to stop these for 10 days pretesting.
    • Currently taking antihistamines and unable to stop these for 4 days pre-testing

Sites / Locations

  • NIHR CRN: Yorkshire and HumberRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

penicillin allergy assessment pathway

Control Arm

Arm Description

Those in the PAAP intervention arm will complete stage 2&3 of the PAAP pathway: Stage-2 assessed for skin testing (ST) and ST done or straight to stage 3 Stage-3 oral challenge test (OCT) All completing PAAP will receive a letter from the immunology clinic giving the results of the test. Also, patients who have tested negative will receive the "Post-test Intervention Booklet" and "Patient Intervention Card" Materials. Additionally, all participants in the PAAP arm will be called by the trial team at days 4-6 and 28-30 post testing to collect safety data. During the call at days 28-30 patients will complete the patient questionnaire on allergy beliefs. Practices will be informed of the test result and instructed to update the participant's electronic health records accordingly.

The usual care arm receive no intervention but will be followed up as per intervention arm with monitoring of any symptoms following an antibiotic prescription.

Outcomes

Primary Outcome Measures

Treatment "response failure"
Treatment "response failure" will be defined as: Re-presentation with worsening or non-resolving symptoms following treatment with an antibiotic up to 28 days after initial antibiotic prescription (including re-prescription of antibiotic within 28 days of an index prescription) for predefined conditions (TPP/notes review), over the year subsequent to randomisation. This will be compared between groups

Secondary Outcome Measures

Symptom duration
Duration of symptoms (in days) rated 'moderately bad' or worse by patients, after initiation of antibiotic treatment
Total antibiotic prescribing
Count of total antibiotic use (measured as total number of days therapy and as average daily quantity (ADQ) antibiotics. Total number of penicillin and each non-penicillin antibiotic prescriptions (measured as total number of days therapy and ADQ)
Hospital admissions
Count of total number of hospital admissions
Length of hospital stays
Count of total length of hospital stays
Mortality rates
Mortality rates compared between intervention arms
Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation
Total number of patients with MRSA infection/colonisation compared between intervention arms
Clostridium difficile infection
Number of patients with Clostridium difficile infection
(Process evaluation) To explore patient and clinician experiences of trial procedures.
GP and patient interviews
To measure changes in clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
Change in self-reported behaviour by clinicians and patients.
To measure the influences on clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
influences on behaviour by clinicians and patients.
Cost effectiveness for the PAAP intervention compared to usual care
Measurement of quality adjusted life years in each arm

Full Information

First Posted
March 5, 2019
Last Updated
February 7, 2020
Sponsor
University of Leeds
Collaborators
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04108637
Brief Title
Allergy Antibiotics And Microbial Resistance
Acronym
ALABAMA
Official Title
Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ALBAMA study is designed to find out if the Penicillin allergy assessment pathway (PAAP) intervention is clinically effective in improving patient health outcomes.
Detailed Description
Antibiotics are important medicines for fighting infections caused by bacteria. Their widespread use has caused a worrying rise in antibiotic resistant bacteria, which are bacteria that are harder to control or kill with antibiotics. Patients with infections caused by antibiotic resistant bacteria are often ill for longer and have an increased risk of serious harm, including death. The spread of resistant bacteria can be slowed down by using antibiotics more carefully. Penicillins are an important group of antibiotics that are recommended treatment for many infections. Doctors will avoid prescribing penicillin for their patients who have a "penicillin allergy label" in their health records. These patients are usually prescribed different types of antibiotics for their infections. There is concern that these non-penicillin antibiotics may not work as well as penicillins, may cause more side-effects (including killing more of the body's "helpful" bacteria), and may be more expensive. About 9 out of 10 people who have a record of penicillin-allergy are found to be not truly allergic to penicillin when thoroughly tested. This means they could safely take penicillins. The aim of ALABAMA is to find out if people with a penicillin-allergy record in their GP health records really do have an allergy by carrying out specialist testing, and to see if it is possible to reduce the number of patients wrongly labelled as penicillin allergic. The investigators will find out if this results in better use of antibiotics and fewer days of symptoms, when patients are prescribed antibiotics for infection. The investigators are asking GPs in West Yorkshire to help with this research, which plans to include 96 people in the initial feasibility study and 1994 people in the main study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
penicillin, allergy, antimicrobial, resistance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentre, two parallel-arm, open label, individually randomised pragmatic trial with a nested-pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2090 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
penicillin allergy assessment pathway
Arm Type
Experimental
Arm Description
Those in the PAAP intervention arm will complete stage 2&3 of the PAAP pathway: Stage-2 assessed for skin testing (ST) and ST done or straight to stage 3 Stage-3 oral challenge test (OCT) All completing PAAP will receive a letter from the immunology clinic giving the results of the test. Also, patients who have tested negative will receive the "Post-test Intervention Booklet" and "Patient Intervention Card" Materials. Additionally, all participants in the PAAP arm will be called by the trial team at days 4-6 and 28-30 post testing to collect safety data. During the call at days 28-30 patients will complete the patient questionnaire on allergy beliefs. Practices will be informed of the test result and instructed to update the participant's electronic health records accordingly.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The usual care arm receive no intervention but will be followed up as per intervention arm with monitoring of any symptoms following an antibiotic prescription.
Intervention Type
Procedure
Intervention Name(s)
penicillin allergy assessment pathway
Other Intervention Name(s)
PAAP
Intervention Description
Summary of penicillin allergy assessment pathway : Stage-1 PAAP in Primary Care - Clinical History. Screening, questionnaire and antimicrobial history will be undertaken in primary care Stage-2 Skin Test(ST) in hospital clinic (this may not be needed for all participants) Stage 3 Oral Challenge Test (OCT) in hospital clinic Testing will involve half a day in clinic and then a three-day post clinic course of oral antimicrobial therapy, without a reaction
Primary Outcome Measure Information:
Title
Treatment "response failure"
Description
Treatment "response failure" will be defined as: Re-presentation with worsening or non-resolving symptoms following treatment with an antibiotic up to 28 days after initial antibiotic prescription (including re-prescription of antibiotic within 28 days of an index prescription) for predefined conditions (TPP/notes review), over the year subsequent to randomisation. This will be compared between groups
Time Frame
Measured after first antibiotic prescription, which can occur any time during 12 month follow-up
Secondary Outcome Measure Information:
Title
Symptom duration
Description
Duration of symptoms (in days) rated 'moderately bad' or worse by patients, after initiation of antibiotic treatment
Time Frame
Up to 28 days after each antibiotic prescription.
Title
Total antibiotic prescribing
Description
Count of total antibiotic use (measured as total number of days therapy and as average daily quantity (ADQ) antibiotics. Total number of penicillin and each non-penicillin antibiotic prescriptions (measured as total number of days therapy and ADQ)
Time Frame
Measured at 12 month post-randomisation
Title
Hospital admissions
Description
Count of total number of hospital admissions
Time Frame
Measured at 12 month post-randomisation
Title
Length of hospital stays
Description
Count of total length of hospital stays
Time Frame
Measured at 12 month post-randomisation
Title
Mortality rates
Description
Mortality rates compared between intervention arms
Time Frame
Measured at 12 month post-randomisation
Title
Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation
Description
Total number of patients with MRSA infection/colonisation compared between intervention arms
Time Frame
Measured 12 month post-randomisation
Title
Clostridium difficile infection
Description
Number of patients with Clostridium difficile infection
Time Frame
Measured 12 month post-randomisation
Title
(Process evaluation) To explore patient and clinician experiences of trial procedures.
Description
GP and patient interviews
Time Frame
Within 12 months of practice recruitment of a proportion of tested patients
Title
To measure changes in clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
Description
Change in self-reported behaviour by clinicians and patients.
Time Frame
Within 12 months of practice recruitment of a proportion of tested patients
Title
To measure the influences on clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
Description
influences on behaviour by clinicians and patients.
Time Frame
Within 12 months of practice recruitment of a proportion of tested patients
Title
Cost effectiveness for the PAAP intervention compared to usual care
Description
Measurement of quality adjusted life years in each arm
Time Frame
Collated for period: randomisation to 12 months of randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study Male or Female, aged 18 years or above Current penicillin allergy (or sensitivity) record of any kind in their electronic health record Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months N.B. Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary. Exclusion Criteria: Life expectancy estimated <1 year by GP Unable to attend immunology clinic Unsuitable for entry into testing pathway because: Allergy history consistent with anaphylaxis to penicillin History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin Previous specialist investigation for penicillin allergy History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle Pregnant Breastfeeding mothers Taking beta blocker medication Currently receiving or due to start immunosuppressive medication Currently taking (or recently taken) systemic steroids and unable to stop these for 10 days pretesting. Currently taking antihistamines and unable to stop these for 4 days pre-testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina Davoudianfar, BA
Phone
01865 289336
Email
mina.davoudianfar@phc.ox.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Sandoe, Dr
Organizational Affiliation
University of Leeds
Official's Role
Study Chair
Facility Information:
Facility Name
NIHR CRN: Yorkshire and Humber
City
York
ZIP/Postal Code
S10 2SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Sandoe, Dr
Phone
0113 3928783
Email
J.Sandoe@leeds.ac.uk
First Name & Middle Initial & Last Name & Degree
Sue Pavitt, Prof
Phone
01133436985
Email
s.pavitt@leeds.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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