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

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589251
First received: December 28, 2007
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Penicillin Allergy
Other: penicillin skin test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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. [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity. [ Time Frame: immediate ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Miguel Park, Mayo clinic
ClinicalTrials.gov Identifier: NCT00589251     History of Changes
Other Study ID Numbers: 301-06
Study First Received: December 28, 2007
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
penicillin allergy, penicillin skin test

Additional relevant MeSH terms:
Drug Hypersensitivity
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014