Penicillin AllergyREPeALNCT06528106
Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
An observational study of Penicillin Allergy, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Penicillin Allergy
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2024to Jun 2025
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.
Who may be able to join
- All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.
Read the detailed description
Aim:
To test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.
Objectives:
- To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)
- To measure the number of patients meeting inclusion criteria (>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.
- To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).
To interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.
- Conditions
- Penicillin Allergy
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start18 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 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
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528106
- Sponsor's protocol ID
- 2324.RCHT.66
- Other IDs
- 335337, NIHR300542
- Acronym
- REPeAL
- Status last verified
- Jun 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)
- ClinicalTrials.gov ID
- NCT06528106
- Acronym / sponsor ID
- REPeAL / 2324.RCHT.66
- Conditions
- Penicillin Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Jul 2024 (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.
To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.
Detailed description
Aim:
To test implementation of the penicillin allergy de-labelling complex intervention in surgical, medical and critical care patient pathway.
Objectives:
- To use the Institute for Health Improvement (IHI) Model for Improvement methodology to implement the penicillin allergy de-labelling complex intervention in each setting (surgery, medicine, critical care)
- To measure the number of patients meeting inclusion criteria (>16 with a penA not prescribed first line antibiotics) who have had their penicillin allergy record assessed by the wider clinical teams and separately by the AMS team.
- To measure the patient uptake of penicillin allergy record removal (i.e. the rate of patient declining de-label / DOC).
To interview 10-15 patients and 10-15 healthcare workers to gain insight into the penicillin allergy de labelling process.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.
Key inclusion criteria (1 listed)
- All adult (>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.
Key exclusion criteria (1 listed)
- None
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
The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Royal Cornwall Hospitals Trust 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 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?
Results are not available in the source record.
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?
The proportion of patients admitted to adult medical, surgical and critical care specialities with a penicillin allergy record, where the allergy record is preventing first line antibiotic therapy, that are safely de-labelled. (time frame: 1 year). 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 30 Jul 2024.