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

Not Applicable

Withdrawn

• Conditions: Penicillin Allergy
• Interventions: Other: penicillin skin test

• Registration Number: NCT00589251
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-09
• Study Start: 2008-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
penicillin skin test	penicillin skin test	Patients will have the skin test placed

Primary Outcome Measures

Name	Time	Method
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

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