Penicillin Allergy Testing and Resensitization Rate

Completed

• Conditions: Penicillin Allergy
• Interventions: Other: Behavioral allergy testing protocol

• Registration Number: NCT03942731
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

Penicillin is one of the earliest discovered antibiotics and a drug of choice for several infections. Up to 10 to 20% of all patients in clinical trial are labeled as penicillin allergic. Most of these patients do not have a true allergy but few have had it verified. Approximately 80% of patients with IgE-mediated penicillin allergy lose their sensitivity after 10 years. Several studies have been conducted denying the risk of sensitization following negative testing of penicillin allergy. Investigators have not had the same experience and have therefore decided to conduct a retrospective study review of 83 adult outpatients with a distant penicillin allergy label and evaluate outcomes of skin retesting six weeks following Drug Provocation Test and challenge.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• 18 years old

Exclusion Criteria

• Pregnancy
• poorly controlled asthma and cardiovascular disease
• use of drugs that interfere with testing and could not be stopped such as antihistamines, tricyclic antidepressants, antipsychotics, beta blockers, high dose oral glucocorticoids
• Non-IgE mediated type of serious allergic reaction such as Stevens - Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Syndrome.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Behavioral allergy testing protocol	83 adult outpatients at CHR Metz-Thionville with penicillin allergy label

Primary Outcome Measures

Name	Time	Method
efficacy of repeated skin testing	week 4	verified efficacy of repeated skin testing 4 weeks or more after drug provocation test and challenge in distant penicillin allergic patients. The reagents used for skin testing were as follow: Penicillin G, Clamoxyl, Augmentin,Tienam, Histamine and Normal saline (negative control). A skin test producing a papule with a diameter greater then 3 mm is considered as positive.

Secondary Outcome Measures

Name	Time	Method
efficacy of allergy testing	Week 4	efficacy of allergy testing in identifying penicillin hypersensitivity reactions. Patients were called to perform, once again skin testing because skin tests sooner could result in false negatives due to the temporary desensitized state.

Trial Locations

Locations (1)

CHR Metz Thionville; 🇫🇷 Thionville, Moselle, France