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This study has been withdrawn prior to enrollment.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

December 28, 2007
December 14, 2011
June 2008
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00589251 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Penicillin Allergy
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.

No Intervention: 1
Patients will have the skin test placed
Intervention: Other: penicillin skin test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00589251
301-06
Not Provided
Miguel Park, Mayo clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP