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

NCT ID: NCT00589251

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Penicillin Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

penicillin skin test

Patients will have the skin test placed

Group Type: OTHER

penicillin skin test

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Miguel Park

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Park, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

301-06

Identifier Type: -

Identifier Source: org_study_id