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

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.

Study Overview

• Status: Withdrawn
• Conditions: Penicillin Allergy
• Intervention / Treatment: Other: penicillin skin test

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: penicillin skin test; Patients will have the skin test placed

Other: penicillin skin test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	immediate

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.	immediate

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Miguel Park, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (Estimate): January 9, 2008

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: penicillin allergy, penicillin skin test
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Penicillins
• Other Study ID Numbers: 301-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided