Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532448
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Evaluating the Feasibility of High-volume Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Feasibility of High-volume Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
De-Label Me
Brief Summary:
Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling but few have addressed how to organise de-labelling at the clinic level This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume The sheer number of patients with a penicillin allergy label in contrast to relatively few allergy centres makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship
Detailed Description:
Participants with a penicillin allergy label will be invited to take part in the study having been referred to the service by their hospital team Based on the information provided with the referral low-risk candidates will be identified
Appointments will be offered to fill 36 clinic slots in total as part of the study
On the day of their appointment after providing written consent participants will be asked some additional questions to confirm their eligibility for penicillin allergy de-labelling and that the information provided in their referral form is accurate Simple medical observations will also be taken recording heart rate blood pressure and oxygen saturation Participants may be asked to return to the waiting area after these initial assessments
Once a chair becomes available in the clinic participants will be given a single dose of penicillin to take by mouth They will then be observed for 1 hour During this time they will be asked to complete a feedback form about their clinic experience
Provided they do not experience a reaction they will then be discharged home where they will be asked to complete a 3-day course of the same penicillin They will be called during the next week to ensure that they completed the course and did not experience any delayed reactions Their GP and the person who referred to the service will be informed of the outcome Those that do not react will be able to receive penicillins in the future
Participants should expect to be in the allergy department for up to 2 hours for their appointment
The study does not need to be powered to make a specific statistical analysis possible the intention is simply to demonstrate that a high-volume de-labelling service is viable However any one session may be affected by factors such as a high DNA rate which would then mean that the clinic model is not tested at optimal capacity To avoid this and to make the overall results more compelling the clinic will run on four occasions with 36 patients in total
Appointments will be offered to fill 36 clinic slots in total as part of the study
On the day of their appointment after providing written consent participants will be asked some additional questions to confirm their eligibility for penicillin allergy de-labelling and that the information provided in their referral form is accurate Simple medical observations will also be taken recording heart rate blood pressure and oxygen saturation Participants may be asked to return to the waiting area after these initial assessments
Once a chair becomes available in the clinic participants will be given a single dose of penicillin to take by mouth They will then be observed for 1 hour During this time they will be asked to complete a feedback form about their clinic experience
Provided they do not experience a reaction they will then be discharged home where they will be asked to complete a 3-day course of the same penicillin They will be called during the next week to ensure that they completed the course and did not experience any delayed reactions Their GP and the person who referred to the service will be informed of the outcome Those that do not react will be able to receive penicillins in the future
Participants should expect to be in the allergy department for up to 2 hours for their appointment
The study does not need to be powered to make a specific statistical analysis possible the intention is simply to demonstrate that a high-volume de-labelling service is viable However any one session may be affected by factors such as a high DNA rate which would then mean that the clinic model is not tested at optimal capacity To avoid this and to make the overall results more compelling the clinic will run on four occasions with 36 patients in total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None