An interventional study of penicillin allergy assessment pathway in Infection, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by University of Leeds · Not applicable, Interventional, and Screening
ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's enrollment of 823 is above the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →University of Leeds is the lead sponsor of 206 studies on the registry; 25 are open to participants now.
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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
Unsuitable for entry into testing pathway because:
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.
N.B.2 Pregnancy and breastfeeding exclusion criteria are only applicable at screening (due to potential risks of PAT); these patients would not need to be withdrawn if in follow up.
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
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.
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 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
Time frame: Measured at up to 12 month post-randomisation
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
Time frame: 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
Duration of symptoms (in days) rated 'moderately bad' or worse by patients, after initiation of antibiotic treatment
Time frame: Measured up to 12 month post-randomisation
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)
Time frame: Measured up to 12 month post-randomisation
Hospital admissions
Count of total number of hospital admissions
Time frame: Measured up to 12 month post-randomisation
Length of hospital stays
Count of total length of hospital stays
Time frame: Measured up to 12 month post-randomisation
Mortality rates
Mortality rates compared between intervention arms
Time frame: Measured up to 12 month post-randomisation
Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation
Total number of patients with MRSA infection/colonisation compared between intervention arms
Time frame: Measured up to 12 month post-randomisation
Clostridium difficile infection
Number of patients with Clostridium difficile infection
Time frame: Measured up to 12 month post-randomisation
(Process evaluation) To explore patient and clinician experiences of trial procedures.
GP and patient interviews
Time frame: 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.
Change in self-reported behaviour by clinicians and patients.
Time frame: 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.
influences on behaviour by clinicians and patients.
Time frame: Within 12 months of practice recruitment of a proportion of tested patients
Cost effectiveness for the PAAP intervention compared to usual care
Measurement of quality adjusted life years in each arm
Time frame: Collated for period: randomisation to up to 12 months of randomisation
De-labelling
The proportion of ALABAMA participants whose labels were removed and remain removed from the medical eHR
Time frame: check performed at 3 and 12 months
AEs and SAEs reported
A descriptive analysis will be performed looking at the safety (number of AEs and SAEs) of de-labelling in the intervention group
Time frame: Measured at up to 12 month post-randomisation
Effects of PAAP on all outcomes for follow up past 12 months
Descriptive analysis using data captured in the notes review CRF
Time frame: Measured at the end of the study
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Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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