Allergy Antibiotics And Microbial Resistance

NCT04108637 | Completed DMC

• 1 other identifier: V14.0 16Nov2023
• Study Type: interventional
• Target: 823
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection

Keywords

penicillin; allergy; antimicrobial; resistance

Outcome Measures

Primary Outcomes (1)

• Penicillin prescribing

  The proportion of participants who receive prescriptions for a penicillin when attending for predefined conditions where a penicillin is the first-line recommended antibiotic

  Measured at up to 12 month post-randomisation

Secondary Outcomes (13)

• Treatment "response failure"

  Measured after first antibiotic prescription, which can occur any time during the follow-up period for patients(Up to 12 months post randomisation)

• Symptom duration

  Measured up to 12 month post-randomisation

• Total antibiotic prescribing

  Measured up to 12 month post-randomisation

• Hospital admissions

  Measured up to 12 month post-randomisation

• Length of hospital stays

  Measured up to 12 month post-randomisation

Other Outcomes (2)

• AEs and SAEs reported

  Measured at up to 12 month post-randomisation

• Effects of PAAP on all outcomes for follow up past 12 months

  Measured at the end of the study

Study Arms (2)

penicillin allergy assessment pathway

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

penicillin allergy assessment pathway 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

Also known as: PAAP

penicillin allergy assessment pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead
• University of Oxford: collaborator

Study Sites (1)

NIHR CRN: Yorkshire and Humber

York, S10 2SB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39363246 DERIVED

• 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.

  PMID: 36691248 DERIVED

MeSH Terms

Conditions

Infections; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jonathan Sandoe, Dr

  University of Leeds

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: Multicentre, two parallel-arm, open label, individually randomised pragmatic trial with a nested-pilot study

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: September 30, 2019
• Study Start: July 4, 2019
• Primary Completion: February 29, 2024
• Study Completion: April 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)