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

Penicillin Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00589251
• Other study ID #: 301-06
• Status: Withdrawn
• Phase: N/A
• First received: December 28, 2007
• Last updated: January 8, 2016
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Penicillin Allergy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.		immediate	No

External Links

•   Mayo Clinic Clinical Trials