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

NCT00589251 | Withdrawn

• 1 other identifier: 301-06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Penicillin Allergy

Keywords

penicillin allergy, penicillin skin test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

  immediate

Study Arms (1)

penicillin skin test

OTHER

Patients will have the skin test placed

Other: penicillin skin test

Interventions

penicillin skin test 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.

penicillin skin test

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of penicillin allergy
• Previous or current positive skin test to penicilloate
• Greater than or equal to 18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Officials

• Miguel Park, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 9, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 11, 2016

Record last verified: 2016-01