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Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique

Primary Purpose

Penicillin Allergy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
penicillin skin test
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Penicillin Allergy focused on measuring penicillin allergy, penicillin skin test

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. History of penicillin allergy
  2. Previous or current positive skin test to penicilloate
  3. Greater than or equal to 18 years of age

Exclusion Criteria:

  1. Uncontrolled asthma by symptoms
  2. Patients who have received penicillin and had no adverse drug reaction
  3. Previous adverse reaction to penicillin skin test
  4. Dermatological conditions that may interfere with skin testing i.e. atopic dermatitis and dermatographism
  5. Medication that may interfere with skin testing i.e. antidepressants, antihistamines, and sedatives.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    penicillin skin test

    Arm Description

    Patients will have the skin test placed

    Outcomes

    Primary Outcome Measures

    The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation.

    Secondary Outcome Measures

    The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

    Full Information

    First Posted
    December 28, 2007
    Last Updated
    January 8, 2016
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00589251
    Brief Title
    Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
    Official Title
    Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funding
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.
    Detailed Description
    The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity. Five (5) adult subjects without a history of penicillin allergy and fifteen (15) adult subjects with a history of penicillin allergy and previous positive penicillin skin test to the minor determinant (penicilloate) and/or major determinant (penicilloyl) will be enrolled into the study. Each subject will be skin tested with our current penicillin skin test which includes penicilloate conducted in the Division of Allergic Diseases will be compared the skin test of our penicilloate prepared by our newer method along with the different diastereoisomers of penicilloic acid on the same day and time. The adult subjects without a history of penicillin allergy will serve as our control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Penicillin Allergy
    Keywords
    penicillin allergy, penicillin skin test

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    penicillin skin test
    Arm Type
    Other
    Arm Description
    Patients will have the skin test placed
    Intervention Type
    Other
    Intervention Name(s)
    penicillin skin test
    Intervention Description
    Prick skin tests will be performed on the volar surface of the forearm with each penicilloate and control reagents. The skin test sites will be examined at 15 minutes. A positive test result is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. Patients with negative prick test results to penicillin will undergo intradermal testing. Intradermal skin tests will be performed on the volar surface of the forearm. The test reagents will be injected intradermally to produce an initial wheal of 2x2 mm. The skin test sites will be examined at 15 minutes. A positive intradermal test is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. In order to ensure patient safety, we will consider using an end point titration technique.
    Primary Outcome Measure Information:
    Title
    The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation.
    Time Frame
    immediate
    Secondary Outcome Measure Information:
    Title
    The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.
    Time Frame
    immediate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: History of penicillin allergy Previous or current positive skin test to penicilloate Greater than or equal to 18 years of age Exclusion Criteria: Uncontrolled asthma by symptoms Patients who have received penicillin and had no adverse drug reaction Previous adverse reaction to penicillin skin test Dermatological conditions that may interfere with skin testing i.e. atopic dermatitis and dermatographism Medication that may interfere with skin testing i.e. antidepressants, antihistamines, and sedatives.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miguel Park, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Links:
    URL
    http://clinicaltrials.mayo.edu
    Description
    Mayo Clinic Clinical Trials

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    Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique

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