Clinical trial NCT00589251: Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
Official title: Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Penicillin Allergy
Keywords: penicillin allergy, penicillin skin test
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
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.
timeFrame: immediate
Secondary outcomes:
measure: The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.
timeFrame: immediate
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Miguel Park, MD
role: PRINCIPAL_INVESTIGATOR
References: