Allergy Antibiotics And Microbial Resistance

University of Leeds823 enrolled

Overview

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

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

823

Conditions

Infection

Interventions

penicillin allergy assessment pathwayPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Locations (1)

NIHR CRN: Yorkshire and Humber

York, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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