Penicillin AllergyIMPAARTNCT07177690
A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes
An observational study of Penicillin Allergy and Antimicrobial Drug Resistance, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Penicillin Allergy, Antimicrobial Drug Resistance, AMR
- How many people
- 214 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2021to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - Workstream 1 population: Participants included in the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH) study (ISRCTN66682918) - Workstream 2 population: Participants will be recruited from patients attending outpatient clinics at Leeds Teaching Hospitals NHS Trust, United Kingdom. - Workstream 3 population: Participants will be recruited from the population of patients participating in the he Allergy Antibiotics and Microbial Resistance (ALABAMA) trial (NCT04108637).
Who may be able to join
- Workstream 1
- Adult (>16 years) with confirmed COVID-19 (positive PCR test)
- Admitted to participating NHS Trusts/hospitals between 01/02/2020 to 30/06/2020
- Workstream 2
- Adult (≥18 years) patients with a penicillin allergy or a matched patients (by age and sex) without a penicillin allergy
- Received antibiotics in the 24 months prior to recruitment
Show all 9Show fewer
- Willing to provide saliva +/- stool samples
- Workstream 3
- Patients enrolled into the ALABAMA trial
Who cannot join
- Workstream 1
- Patients with their allergy status missing will be excluded.
- Workstream 2
- Patients unable to give informed consent or who are unwilling/unable to provide saliva samples
- Unwilling/unable to provide saliva samples
- Workstream 3
- Patients unable to give informed consent or who are unwilling/unable to provide saliva samples
- Unwilling/unable to provide saliva samples
Trial locations and contacts
1 site in 1 country.
About this study
Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a greater propensity to drive antimicrobial resistance (AMR). Most patients with penicillin allergy records do not have a true allergy when they are tested by a specialist, so many patients are denied the best antibiotics because of an incorrect penicillin allergy record.
The study will investigate how having a penicillin allergy impacts on treatment for patients who need antibiotics when they are hospitalised with COVID-19 and how penicillin allergy affects AMR.
Read more
Antibiotic use is the main driver of AMR, antibiotic use can also disrupt the bacteria that normally live in our guts and mouths. These bacterial communities also known as the gastrointestinal (GI) and oral microbiome respectively, help us digest food and prevent infections. Antibiotic use can 'kill off' these harmless bacteria and lead to an increase in bacteria which have genes that make them resistant to antibiotics (antibiotic resistance genes). The study investigators believe that patients with penicillin allergy are likely to have a greater number of antibiotic resistance genes in their oral and GI microbiomes, ans that this will make it more likely that they will fail antibiotic treatment and will increase their risk of transmitting resistance to others.
The study objectives are:
- To determine how penicillin allergy impacts on clinical outcomes in patients admitted with COVID-19
- To find out if AMR genes in the oral microbiome of people with a penicillin allergy record are different to those without a penicillin allergy record
- To investigate whether AMR genes are lost in patients who have an incorrect penicillin allergy label removed
Read the detailed description
Study hypothesis:
Patients with a penicillin allergy record are more likely to have resistance to non-penicillin antibiotics in their normal flora and that this will increase their risk of treatment failure with non-penicillin antibiotics. In particular, penicillin allergic patients admitted with COVID-19 who have bacterial infections will have an increased risk of treatment failure and poor outcomes.
Study design:
This research will be conducted in three separate but complementary workstreams:
Workstream 1 will include secondary analysis of data collected as a part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH) study (ISRCTN66682918) to determine how penicillin allergy impacts on antibiotic use and clinical outcomes in patients admitted with COVID-19. The PEACH study was a multi-centre, retrospective, observational, cohort study using patient-level clinical data which investigated whether the use of procalcitonin testing, to guide antibiotic prescribing, safely reduced antibiotic use amongst hospitalised patients with COVID-19 during the first wave of the pandemic using routinely collected patient institutional clinical databases and patient medical records. Data were collected in 11 National Health Service (NHS) acute hospital Trusts and Health Boards in England and Wales, and data in a pseudo-anonymised format was received from the Cardiff Clinical Trials Unit who were the data controllers for the PEACH study.
Workstream 2 will compare the oral resistome of patients with and without penicillin allergy. Metagenomic and metatranscriptomic analysis will be used for resistome assessment.
Workstream 3 will determine the feasibility of investigating if antibiotic resistance genes are lost after removal of an incorrect penicillin allergy record. This workstream will recruit patients enrolled in the Allergy Antibiotics and Microbial Resistance (ALABAMA) trial (NCT04108637), which is a randomised control trial (RCT) designed to assess the effect of removing incorrect penicillin allergy records on health outcomes. Participants are randomised to either usual care or the intervention group where they receive a novel penicillin allergy assessment pathway (PAAP), if patients in the intervention group are found to be not allergic to penicillin, their allergy label is subsequently removed. Patients recruited to this workstream will be followed up as per the ALABAMA protocol but will also be required to provide baseline and follow up (> 6 months after enrolment or allergy testing) saliva +/- stool samples. Metagenomic and metatranscriptomic analysis will be used for resistome assessment.
- Conditions
- Penicillin Allergy, Antimicrobial Drug Resistance, AMR
- Keywords
- penicillin allergy, AMR, Antimicrobial resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Workstream 1: PEACH Study participants | Adults and adolescents 16 years old and older, admitted to hospital between 1/2/20 and 30/06/20 with a positive SARS-CoV-2 test. | |
| Workstream 2 exposure group | Adult patients with a penicillin allergy attending immunology clinics at Leeds Teaching Hospitals, UK | |
| Workstream 2 comparator group | Adult patients without a penicillin allergy attending immunology clinics at Leeds Teaching Hospitals, UK | |
| Workstream 3 exposure group | Participants enrolled in the ALABAMA trial who underwent penicillin allergy testing | |
| Workstream 3 comparator group | Participants enrolled in the ALABAMA trial who had usual care only (i.e. did not undergo penicillin allergy testing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workstream 1: 60 day mortality in patients with and without penicillin allergy
This outcome will measure mortality within 60 days of positive COVID-19 test. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: 60 days from the date of positive COVID 19 test
Workstream 2: The prevalence of antibiotic resistance genes (ARGs) in the mouth of patients with and without a penicillin allergy record.
The prevalence of ARGs will be assessed using shotgun metagenomic sequencing of saliva samples. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: At enrolment
Workstream 3: Change in abundance of antibiotic resistance genes in saliva samples collected from participants enrolled in the ALABAMA trial
This outcome will determine the change in antibiotic resistance gene (ARG) abundance over time in patients who received the ALABAMA trial intervention (penicillin allergy assessment) compared to those in the control group (no penicillin allergy assessment). This analysis will focus on the subset of ALABAMA trial patients with at least one antibiotic prescription prior to their second saliva sampling. Comparative analysis will be conducted between the penicillin allergy assessment group and the no penicillin allergy assessment group.
Measured: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection)
Secondary outcomes (13)
Workstream 1: Length of hospital stay in patients with and without a penicillin allergy.
This will be determined by a retrospective measurement of total hospital stay (day 0 = date of admission), calculated as days from admission date to the date of discharge or inpatient death (whichever occurred first). Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Number of AMR bacterial infections in patients with and without a penicillin allergy.
This will be determined by blood cultures and deep respiratory culture positivity, and a infection will be considered to be a AMR/resistant infection if the isolated pathogen is resistant to ≥1 antibiotic agent in 3 or more antibiotic classes. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Total antibiotic usage in patients with and without a penicillin allergy.
This outcome will assess inpatient antibiotic use including antibiotic agent, route of administration and duration following COVID-19 diagnosis in hospital from day 1 of COVID-19 diagnosis to date of discharge or death (inclusive of day 1 and last day). Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Rates of treatment failure in patients with and without a penicillin allergy.
This will be defined as re-prescription of an antibiotic within 30 days of index antibiotic prescription. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: ICU admission rates in patients with and without a penicillin allergy.
The number of admission to intensive care units (ICU) will be counted. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Rate of Clostridioides difficile infection in patients with and without a penicillin allergy.
This will be determined by a toxin positive result from day 1 of COVID-19 diagnosis. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: 30 day mortality in patients with and without a penicillin allergy
This outcome will measure mortality within 30 days of COVID-19 diagnosis in patients with and without penicillin allergy.
Measured: 30 days from COVID-19 diagnosis
Workstream 2: The difference in diversity of antibiotic resistance genes (ARGs) in oral microbiome of patients with and without a penicillin allergy record.
This outcome will assess the diversity of ARGs using shotgun metagenomic and metatranscriptomic sequencing of saliva samples collected at the time of enrolment. Bioinformatic analysis will be performed to quantify the overall counts, relative abundance, and diversity indices (e.g., Shannon and Simpson diversity) of ARGs. Comparative analysis will be conducted between patients with and without penicillin allergy to determine differences in ARG diversity.
Measured: Enrolment
Workstream 2: The number of resistance genes to specific antibiotic classes present in the oral microbiome of patients with and without a penicillin allergy record.
This outcome will assess the number antibiotic resistance genes (ARGs) associated with specific antibiotic classes using shotgun metagenomic sequencing of saliva samples. A comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Measured: Enrolment
Workstream 2: To determine whether a metagenomic or transcriptomic approach could be used to predict phenotypic antibiotic susceptibility
This outcome will evaluate whether of shotgun metagenomic and metatranscriptomic sequencing of saliva samples can be used to predict phenotypic antibiotic susceptibility. Saliva samples taken at enrolment will undergo metagenomic and transcriptomic sequencing analysis to identify antibiotic resistance genes and their expression as well as antimicrobial susceptibility testing (AST) on cultured bacterial isolates from the same samples to determine actual resistance profiles.
Measured: Enrolment
Workstream 3: The change in the abundance and richness of antibiotic resistance genes (ARGs) over time between patients who had the ALABAMA trial intervention and those in the control group
This outcome will assess the change over time in the abundance and richness of ARGs in the oral microbiome, and where available, the gut microbiome. Samples will be analysed using shotgun metagenomic sequencing of saliva and optional stool samples. Bioinformatic analysis will include overall ARG counts, relative abundance and diversity indices (e.g., Shannon and Simpson diversity).
Comparative analysis will be conducted between patients who received the intervention (penicillin allergy assessment) and those in the control group (no penicillin allergy assessment) to evaluate differences in ARG dynamics over time.
Measured: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection).
Workstream 3: The number and abundance of 'non-penicillin' antibiotic resistance genes in patients who had the ALABAMA trial intervention (penicillin allergy assessment) and those in the control group (no penicillin allergy assessment).
This outcome will assess the number and abundance of ARGs associated with non-penicillin antibiotic classes (e.g., macrolides, tetracyclines, fluoroquinolones, aminoglycosides) in the oral microbiome, and where available, the gut microbiome. Comparative analysis will be conducted between patients who received the intervention and those in the control group to evaluate differences in ARG dynamics over time.
Measured: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection)
Workstream 3: The number and abundance of 'penicillin' antibiotic resistance genes (ARGs) in patients who had the ALABAMA trial intervention (penicillin allergy assessment) and those in the control group (no penicillin allergy assessment).
This outcome will assess the number and abundance of ARGs specifically associated with penicillin-class antibiotics in the oral microbiome, and where available, the gut microbiome. Comparative analysis will be conducted between patients who received the intervention and those in the control group to evaluate differences in ARG dynamics over time.
Measured: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start30 Nov 2021
- Primary completion24 Apr 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin AllergyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sandoe, University of Leeds
- Investigators
- Shadia Ahmed, MBChB, Principal investigator, Univeristy of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177690
- Sponsor's protocol ID
- Version 1. 3 25/01/2022
- Acronym
- IMPAART
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes
- ClinicalTrials.gov ID
- NCT07177690
- Acronym / sponsor ID
- IMPAART / Version 1. 3 25/01/2022
- Conditions
- Penicillin Allergy, Antimicrobial Drug Resistance, AMR
- Keywords
- penicillin allergy, AMR, Antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Sep 2025 (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.
Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a greater propensity to drive antimicrobial resistance (AMR). Most patients with penicillin allergy records do not have a true allergy when they are tested by a specialist, so many patients are denied the best antibiotics because of an incorrect penicillin allergy record.
The study will investigate how having a penicillin allergy impacts on treatment for patients who need antibiotics when they are hospitalised with COVID-19 and how penicillin allergy affects AMR.
Antibiotic use is the main driver of AMR, antibiotic use can also disrupt the bacteria that normally live in our guts and mouths. These bacterial communities also known as the gastrointestinal (GI) and oral microbiome respectively, help us digest food and prevent infections. Antibiotic use can 'kill off' these harmless bacteria and lead to an increase in bacteria which have genes that make them resistant to antibiotics (antibiotic resistance genes). The study investigators believe that patients with penicillin allergy are likely to have a greater number of antibiotic resistance genes in their oral and GI microbiomes, ans that this will make it more likely that they will fail antibiotic treatment and will increase their risk of transmitting resistance to others.
The study objectives are:
- To determine how penicillin allergy impacts on clinical outcomes in patients admitted with COVID-19
- To find out if AMR genes in the oral microbiome of people with a penicillin allergy record are different to those without a penicillin allergy record
- To investigate whether AMR genes are lost in patients who have an incorrect penicillin allergy label removed
Detailed description
Study hypothesis:
Patients with a penicillin allergy record are more likely to have resistance to non-penicillin antibiotics in their normal flora and that this will increase their risk of treatment failure with non-penicillin antibiotics. In particular, penicillin allergic patients admitted with COVID-19 who have bacterial infections will have an increased risk of treatment failure and poor outcomes.
Study design:
This research will be conducted in three separate but complementary workstreams:
Workstream 1 will include secondary analysis of data collected as a part of the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH) study (ISRCTN66682918) to determine how penicillin allergy impacts on antibiotic use and clinical outcomes in patients admitted with COVID-19. The PEACH study was a multi-centre, retrospective, observational, cohort study using patient-level clinical data which investigated whether the use of procalcitonin testing, to guide antibiotic prescribing, safely reduced antibiotic use amongst hospitalised patients with COVID-19 during the first wave of the pandemic using routinely collected patient institutional clinical databases and patient medical records. Data were collected in 11 National Health Service (NHS) acute hospital Trusts and Health Boards in England and Wales, and data in a pseudo-anonymised format was received from the Cardiff Clinical Trials Unit who were the data controllers for the PEACH study.
Workstream 2 will compare the oral resistome of patients with and without penicillin allergy. Metagenomic and metatranscriptomic analysis will be used for resistome assessment.
Workstream 3 will determine the feasibility of investigating if antibiotic resistance genes are lost after removal of an incorrect penicillin allergy record. This workstream will recruit patients enrolled in the Allergy Antibiotics and Microbial Resistance (ALABAMA) trial (NCT04108637), which is a randomised control trial (RCT) designed to assess the effect of removing incorrect penicillin allergy records on health outcomes. Participants are randomised to either usual care or the intervention group where they receive a novel penicillin allergy assessment pathway (PAAP), if patients in the intervention group are found to be not allergic to penicillin, their allergy label is subsequently removed. Patients recruited to this workstream will be followed up as per the ALABAMA protocol but will also be required to provide baseline and follow up (> 6 months after enrolment or allergy testing) saliva +/- stool samples. Metagenomic and metatranscriptomic analysis will be used for resistome assessment.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Workstream 1: PEACH Study participants | – | –Adults and adolescents 16 years old and older, admitted to hospital between 1/2/20 and 30/06/20 with a positive SARS-CoV-2 test. |
| Workstream 2 exposure group | – | –Adult patients with a penicillin allergy attending immunology clinics at Leeds Teaching Hospitals, UK |
| Workstream 2 comparator group | – | –Adult patients without a penicillin allergy attending immunology clinics at Leeds Teaching Hospitals, UK |
| Workstream 3 exposure group | – | –Participants enrolled in the ALABAMA trial who underwent penicillin allergy testing |
| Workstream 3 comparator group | – | –Participants enrolled in the ALABAMA trial who had usual care only (i.e. did not undergo penicillin allergy testing) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Workstream 1 population: Participants included in the Procalcitonin Evaluation of Antibiotic use in COVID-19 Hospitalised patients (PEACH) study (ISRCTN66682918) - Workstream 2 population: Participants will be recruited from patients attending outpatient clinics at Leeds Teaching Hospitals NHS Trust, United Kingdom. - Workstream 3 population: Participants will be recruited from the population of patients participating in the he Allergy Antibiotics and Microbial Resistance (ALABAMA) trial (NCT04108637).
Key inclusion criteria (9 listed)
- Workstream 1
- Workstream 2
- Workstream 3
Key exclusion criteria (8 listed)
- Workstream 1
- Workstream 2
- Workstream 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Workstream 1: 60 day mortality in patients with and without penicillin allergy
Time frame: 60 days from the date of positive COVID 19 test
This outcome will measure mortality within 60 days of positive COVID-19 test. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Workstream 2: The prevalence of antibiotic resistance genes (ARGs) in the mouth of patients with and without a penicillin allergy record.
Time frame: At enrolment
The prevalence of ARGs will be assessed using shotgun metagenomic sequencing of saliva samples. Comparative analysis will be conducted between patients with and without a documented penicillin allergy.
Workstream 3: Change in abundance of antibiotic resistance genes in saliva samples collected from participants enrolled in the ALABAMA trial
Time frame: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection)
This outcome will determine the change in antibiotic resistance gene (ARG) abundance over time in patients who received the ALABAMA trial intervention (penicillin allergy assessment) compared to those in the control group (no penicillin allergy assessment). This analysis will focus on the subset of ALABAMA trial patients with at least one antibiotic prescription prior to their second saliva sampling. Comparative analysis will be conducted between the penicillin allergy assessment group and the no penicillin allergy assessment group.
13 secondary outcomes
Workstream 1: Length of hospital stay in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Number of AMR bacterial infections in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Total antibiotic usage in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Rates of treatment failure in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: ICU admission rates in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: Rate of Clostridioides difficile infection in patients with and without a penicillin allergy.
Time frame: Time of hospital admission to discharge or inpatient death for each patient, assessed up to 600 days
Workstream 1: 30 day mortality in patients with and without a penicillin allergy
Time frame: 30 days from COVID-19 diagnosis
Workstream 2: The difference in diversity of antibiotic resistance genes (ARGs) in oral microbiome of patients with and without a penicillin allergy record.
Time frame: Enrolment
Workstream 2: The number of resistance genes to specific antibiotic classes present in the oral microbiome of patients with and without a penicillin allergy record.
Time frame: Enrolment
Workstream 2: To determine whether a metagenomic or transcriptomic approach could be used to predict phenotypic antibiotic susceptibility
Time frame: Enrolment
Workstream 3: The change in the abundance and richness of antibiotic resistance genes (ARGs) over time between patients who had the ALABAMA trial intervention and those in the control group
Time frame: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection).
Workstream 3: The number and abundance of 'non-penicillin' antibiotic resistance genes in patients who had the ALABAMA trial intervention (penicillin allergy assessment) and those in the control group (no penicillin allergy assessment).
Time frame: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection)
Workstream 3: The number and abundance of 'penicillin' antibiotic resistance genes (ARGs) in patients who had the ALABAMA trial intervention (penicillin allergy assessment) and those in the control group (no penicillin allergy assessment).
Time frame: At enrolment (first sample collection) and 6 to 12 months post-enrolment (second sample collection).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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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.
Shadia Ahmed, MBChB principal investigator
Univeristy of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penicillin Allergy and Antimicrobial Drug Resistance, 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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Workstream 1: 60 day mortality in patients with and without penicillin allergy (time frame: 60 days from the date of positive COVID 19 test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.