Evaluation of Skin Testing Reagents for Penicillin Allergy
Public ClinicalTrials.gov record NCT01818336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01818336
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 481 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2012
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Jan 3, 2017
2012 – 2013
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Allergy & Asthma Center | Homewood | Alabama | 35209 | — |
| Allergy Associates of Tucson | Tucson | Arizona | 85716 | — |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94590 | — |
| Fairfield County Allergy, Asthma & Immunology Assoc., Inc. | Norwalk | Connecticut | 06851 | — |
| Ct. Asthma & Allergy Center LLC | West Hartford | Connecticut | 06119 | — |
| Windom Allergy | Sarasota | Florida | 34233 | — |
| Atlanta Allergy and Asthma Clinic | Atlanta | Georgia | 30060 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University Medical School | St Louis | Missouri | 63110 | — |
| Midwest Allergy & Asthma Clinic PC | Omaha | Nebraska | 68130 | — |
| Corvallis Clinic | Corvallis | Oregon | 97330 | — |
| Allergy & Asthma Care | Germantown | Tennessee | 38138 | — |
| Northwest Asthma & Allergy Center | Redmond | Washington | 98052 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01818336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 3, 2017 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01818336 live on ClinicalTrials.gov.