Allergy Antibiotics And Microbial Resistance

NCT ID: NCT04108637

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 823 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2024-04-30

Brief Summary

ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing

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 recruiting up to 140 GP practices in Yorkshire and Humber and the South West Peninsula to help with this research, and plans to include up to 1060 people.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

penicillin allergy assessment pathway

Intervention Type: PROCEDURE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

PAAP

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.1 Patients who have been formally tested for penicillin allergy in the past and been found not to be penicillin allergic but still have a medical record indicating a penicillin allergy, are eligible for the trial.

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
• Has been formally tested for penicillin allergy in the past and been found to be penicillin allergic
• History of brittle/severe asthma or has had a course of steroids in the past 3 months for asthma 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, and unable to temporarily withhold these on the day of penicillin allergy testing
• Currently taking (or recently taken) systemic steroids and unable to stop these for 10 days pretesting.
• Currently taking antihistamines and unable to temporarily withhold these for 72 hours pre-testing

GPs may also want to exclude vulnerable patients who are deemed to be unsuitable to participate for other reasons such as, but not limited to, terminal illness, reliability, mental illness, learning difficulties, anxiety, and other family circumstances.

N.B.1 Patients that are currently taking medicines with antihistamine properties that cannot be temporarily withheld, or patients with isolated dermographism, may still be eligible to participate but will need to be discussed with the research team prior to consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Sandoe

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Sandoe, Dr

Role: STUDY_CHAIR

University of Leeds

Locations

NIHR CRN: Yorkshire and Humber

York, , United Kingdom

Countries

United Kingdom

References

Ahmed S, Fielding J, Porter CE, Armitage KF, Wanat M, Bates C, Engonidou L, West RM, Yu LM, Galal U, Howard P, Butler CC, Savic S, Boards J, Tonkin-Crine S, Parry J, Pavitt SA, Sandoe JT; ALABAMA research team. Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment. Trials. 2024 Oct 3;25(1):653. doi: 10.1186/s13063-024-08506-x.

Reference Type: DERIVED

PMID: 39363246 (View on PubMed)

Wanat M, Santillo M, Galal U, Davoudianfar M, Bongard E, Savic S, Savic L, Porter C, Fielding J, Butler CC, Pavitt S, Sandoe J, Tonkin-Crine S; ALABAMA team. Mixed-methods evaluation of a behavioural intervention package to identify and amend incorrect penicillin allergy records in UK general practice. BMJ Open. 2022 Jun 3;12(6):e057471. doi: 10.1136/bmjopen-2021-057471.

Reference Type: DERIVED

PMID: 36691248 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V14.0 16Nov2023

Identifier Type: -

Identifier Source: org_study_id