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

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ClinicalTrials.gov Identifier: NCT00589251
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 9, 2008
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Miguel Park, 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.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Other: penicillin skin test Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
Study Start Date : June 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
penicillin skin test
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.




Primary Outcome Measures :
  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. [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity. [ Time Frame: immediate ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589251


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Miguel Park, MD Mayo Clinic

Additional Information:
Responsible Party: Miguel Park, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589251     History of Changes
Other Study ID Numbers: 301-06
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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