Penicillin Allergy Delabeling Among Surgical Patients (PenDel)
Primary Purpose
Penicillin Allergy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allergy testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Penicillin Allergy
Eligibility Criteria
Inclusion Criteria: surgical patients with reported penicillin allergy Exclusion Criteria: missing consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Allergy testing
Arm Description
Outcomes
Primary Outcome Measures
Confirmed penicillin allergy
Secondary Outcome Measures
Full Information
NCT ID
NCT05956080
First Posted
July 13, 2023
Last Updated
July 13, 2023
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT05956080
Brief Title
Penicillin Allergy Delabeling Among Surgical Patients
Acronym
PenDel
Official Title
Penicillin Allergy Delabeling Among Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Penicillin allergy testing among surgical patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allergy testing
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Allergy testing
Intervention Description
University Medicine Greifswald
Primary Outcome Measure Information:
Title
Confirmed penicillin allergy
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
surgical patients with reported penicillin allergy
Exclusion Criteria:
missing consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Gibb, MD
Phone
00493834 86 5801
Email
sebastian.gibb@med.uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Gibb, MD
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian S. Scheer, MD
Organizational Affiliation
University Medicine Greifswald
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Penicillin Allergy Delabeling Among Surgical Patients
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