NCT06528106

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 30, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

July 25, 2024

Last Update Submit

July 25, 2024

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

You may qualify if:

  • All adult (\>16) patients admitted to hospital over the study period with a penicillin allergy record preventing first line antibiotic use.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

June 18, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

July 30, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)