Evaluation of Skin Testing Reagents for Penicillin Allergy
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|ClinicalTrials.gov Identifier: NCT01818336|
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : January 4, 2017
Last Update Posted : January 4, 2017
A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000, Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the penicillins can safely take these antibiotics without fear of a life-threatening reaction (Gadde et al. 1993, Macy et al. 1997). The outcomes of this erroneous classification of patients include unnecessary denial of an effective and well-tolerated class of antibiotics, which are often the treatment of choice.
The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at very low risk of developing acute IgE-dependent reactions when given a penicillin or cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral challenge with a penicillin.
|Condition or disease||Intervention/treatment||Phase|
|History of IgE Dependent Reaction to a Penicillin Product||Drug: Penicillin skin test kit||Phase 3|
This is a prospective, open-label investigation of skin testing with the Penicillin Skin Test Kit in subjects at least 18 years of age with a self-reported history of possible IgE-dependent penicillin hypersensitivity.
At screening on Day 1, subjects and their parents/legal guardians (if applicable) will sign the informed consent form/ pediatric assent form. Following consent/assent, demographic information and medical history will be obtained, including prior and current medication use. Subjects will also be asked if they have had a respiratory infection in the past 2 weeks or antibiotics within the past 4 weeks. A physical examination will be performed, along with measurements of vital signs and, in subjects >5 years of age with active asthma, peak expiratory flow rate (PEFR). A urine pregnancy test will be obtained for all female subjects of childbearing potential.
The skin test procedure will first involve puncture testing. Skin test reagents will include the Penicillin Skin Test Kit, histamine (positive control), and sodium chloride (negative control). Subjects who have negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit will then undergo intradermal testing in duplicate. Subjects who have a positive reaction to one or more puncture or intradermal tests contained within the Penicillin Skin Test Kit will be discharged from the study. However, subjects with any positive skin test to drug antigens in the Penicillin Skin Test Kit will be asked to return for retesting (puncture and intradermal) in 4 weeks.
Subjects who have negative puncture and intradermal test results will be given the oral amoxicillin challenge, which will be comprised of a single, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge is to confirm lack of allergy and confirm the NPV (Negative Predictive Value) of skin testing. Subjects will be monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site will follow-up by telephone with all subjects (or their parents/legal guardians in the case of young children) ≥72 hours after administration of the oral amoxicillin challenge.
Adverse events (AEs) will be recorded from administration of the Penicillin Skin Test throughout the 3-day study period as spontaneously reported by subjects or observed by the site staff.
Two normal subjects (i.e., no history of penicillin allergy) will be skin tested at each site to provide data on skin test specificity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||481 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Confirmatory Study to Examine Negative Predictive Value (NPV) and Safety of Skin Testing With PRE-PEN, a Minor Determinant MIxture (MDM) of Penicillin Antigens, and Amoxicillin Reagent Against an Oral Challenge With Amoxicillin|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: all subjects
Intervention: Penicillin skin test kit
Subjects with negative intradermal tests will be given single oral amoxicillin challenge dose and followed for 72 hours for IgE dependent reactions.
Drug: Penicillin skin test kit
Allergy skin testing is done by puncture and intradermal. If all tests negative, subjects receive an oral amoxicillin challenge.
- Negative Predictive Value [ Time Frame: 72 hours ]The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.
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): NCT01818336
|United States, Alabama|
|Alabama Allergy & Asthma Center|
|Homewood, Alabama, United States, 35209|
|United States, Arizona|
|Allergy Associates of Tucson|
|Tucson, Arizona, United States, 85716|
|United States, California|
|Allergy & Asthma Clinical Research|
|Walnut Creek, California, United States, 94590|
|United States, Connecticut|
|Fairfield County Allergy, Asthma & Immunology Assoc., Inc.|
|Norwalk, Connecticut, United States, 06851|
|Ct. Asthma & Allergy Center LLC|
|West Hartford, Connecticut, United States, 06119|
|United States, Florida|
|Sarasota, Florida, United States, 34233|
|United States, Georgia|
|Atlanta Allergy and Asthma Clinic|
|Atlanta, Georgia, United States, 30060|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University Medical School|
|St. Louis, Missouri, United States, 63110|
|United States, Nebraska|
|Midwest Allergy & Asthma Clinic PC|
|Omaha, Nebraska, United States, 68130|
|United States, Oregon|
|Corvallis, Oregon, United States, 97330|
|United States, Tennessee|
|Allergy & Asthma Care|
|Germantown, Tennessee, United States, 38138|
|United States, Washington|
|Northwest Asthma & Allergy Center|
|Redmond, Washington, United States, 98052|
|Study Director:||N. Franklin Adkinson, Jr., MD||AllerQuest LLC|