InfectionALABAMANCT04108637
Allergy Antibiotics And Microbial Resistance
A study testing penicillin allergy assessment pathway in people with Infection, run by University of Leeds at 1 site in United Kingdom.
Trial summary
ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- penicillin allergy assessment pathway
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance
ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing
Read the 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
- Being tested
- penicillin allergy assessment pathway
- Keywords
- penicillin, allergy, antimicrobial, resistance
- Medical subject headings
- Infections, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penicillin allergy assessment pathwayProcedure or surgery
Also called PAAP
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at up to 12 month post-randomisation
Secondary outcomes (13)
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
Measured: 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
Measured: 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)
Measured: Measured up to 12 month post-randomisation
Hospital admissions
Count of total number of hospital admissions
Measured: Measured up to 12 month post-randomisation
Length of hospital stays
Count of total length of hospital stays
Measured: Measured up to 12 month post-randomisation
Mortality rates
Mortality rates compared between intervention arms
Measured: 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
Measured: Measured up to 12 month post-randomisation
Clostridium difficile infection
Number of patients with Clostridium difficile infection
Measured: Measured up to 12 month post-randomisation
(Process evaluation) To explore patient and clinician experiences of trial procedures.
GP and patient interviews
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: check performed at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start4 Jul 2019
- Primary completion29 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, two parallel-arm, open label, individually randomised pragmatic trial with a nested-pilot study
- Masking
- None (open label)
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Jonathan Sandoe, University of Leeds
- Investigators
- Jonathan Sandoe, Dr, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108637
- Sponsor's protocol ID
- V14.0 16Nov2023
- Acronym
- ALABAMA
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2019
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39363246Wanat 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.
PubMed 36691248
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance
- ClinicalTrials.gov ID
- NCT04108637
- Acronym / sponsor ID
- ALABAMA / V14.0 16Nov2023
- Conditions
- Infection
- Keywords
- penicillin, allergy, antimicrobial, resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, two parallel-arm, open label, individually randomised pragmatic trial with a nested-pilot study
| Arm | Type | Receives |
|---|---|---|
| penicillin allergy assessment pathway | Experimental | Procedure: penicillin allergy assessment pathwayThose 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- Life expectancy estimated <1 year by GP
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| penicillin allergy assessment pathwayAlso: PAAPSummary 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 | Procedure or surgery | penicillin allergy assessment pathway |
Primary outcome
Penicillin prescribing
Time frame: Measured at up to 12 month post-randomisation
The proportion of participants who receive prescriptions for a penicillin when attending for predefined conditions where a penicillin is the first-line recommended antibiotic
13 secondary outcomes
Treatment "response failure"
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
Time frame: Measured up to 12 month post-randomisation
Total antibiotic prescribing
Time frame: Measured up to 12 month post-randomisation
Hospital admissions
Time frame: Measured up to 12 month post-randomisation
Length of hospital stays
Time frame: Measured up to 12 month post-randomisation
Mortality rates
Time frame: Measured up to 12 month post-randomisation
Meticillin-resistant Staphylococcus aureus (MRSA) infection/ colonisation
Time frame: Measured up to 12 month post-randomisation
Clostridium difficile infection
Time frame: Measured up to 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
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
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
Cost effectiveness for the PAAP intervention compared to usual care
Time frame: Collated for period: randomisation to up to 12 months of randomisation
De-labelling
Time frame: check performed at 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 39363246Ahmed 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.
- Derived from this study: PubMed 36691248Wanat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Sandoe, Dr study chair
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing penicillin allergy assessment pathway in people with Infection, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penicillin prescribing (time frame: Measured at up to 12 month post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.