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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
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Penicillin Allergy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 13, 2023
    Last Updated
    July 13, 2023
    Sponsor
    University Medicine Greifswald
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    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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