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Withdrawn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Withdrawn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