Allergy Antibiotics And Microbial Resistance (ALABAMA)

February 7, 2020 updated by: Jonathan Sandoe, University of Leeds

Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance

ALBAMA study is designed to find out if the Penicillin allergy assessment pathway (PAAP) intervention is clinically effective in improving patient health outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2090

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: penicillin allergy assessment pathway

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.
Procedure: penicillin allergy assessment pathway

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

Other Names:
  • PAAP
NO_INTERVENTION: Control Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment "response failure"
Time Frame: Measured after first antibiotic prescription, which can occur any time during 12 month follow-up
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
Measured after first antibiotic prescription, which can occur any time during 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom duration
Time Frame: Up to 28 days after each antibiotic prescription.
Duration of symptoms (in days) rated 'moderately bad' or worse by patients, after initiation of antibiotic treatment
Up to 28 days after each antibiotic prescription.
Total antibiotic prescribing
Time Frame: Measured at 12 month post-randomisation
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)
Measured at 12 month post-randomisation
Hospital admissions
Time Frame: Measured at 12 month post-randomisation
Count of total number of hospital admissions
Measured at 12 month post-randomisation
Length of hospital stays
Time Frame: Measured at 12 month post-randomisation
Count of total length of hospital stays
Measured at 12 month post-randomisation
Mortality rates
Time Frame: Measured at 12 month post-randomisation
Mortality rates compared between intervention arms
Measured at 12 month post-randomisation
Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation
Time Frame: Measured 12 month post-randomisation
Total number of patients with MRSA infection/colonisation compared between intervention arms
Measured 12 month post-randomisation
Clostridium difficile infection
Time Frame: Measured 12 month post-randomisation
Number of patients with Clostridium difficile infection
Measured 12 month post-randomisation
(Process evaluation) To explore patient and clinician experiences of trial procedures.
Time Frame: Within 12 months of practice recruitment of a proportion of tested patients
GP and patient interviews
Within 12 months of practice recruitment of a proportion of tested patients
To measure changes in clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
Time Frame: Within 12 months of practice recruitment of a proportion of tested patients
Change in self-reported behaviour by clinicians and patients.
Within 12 months of practice recruitment of a proportion of tested patients
To measure the influences on clinician and patient behaviour change regarding prescribing and consuming penicillin following a negative test result.
Time Frame: Within 12 months of practice recruitment of a proportion of tested patients
influences on behaviour by clinicians and patients.
Within 12 months of practice recruitment of a proportion of tested patients
Cost effectiveness for the PAAP intervention compared to usual care
Time Frame: Collated for period: randomisation to 12 months of randomisation
Measurement of quality adjusted life years in each arm
Collated for period: randomisation to 12 months of randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

University of Oxford

Investigators

  • Study Chair: Jonathan Sandoe, Dr, University of Leeds

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2019

Primary Completion (ANTICIPATED)

February 28, 2023

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

March 5, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (ACTUAL)

September 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V3.0 06Dec2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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