Penicillin Allergy Testing and Resensitization Rate

NCT03942731 | Completed

• 1 other identifier: 2019-03Obs-CHRMT
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

• efficacy of repeated skin testing

  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.

  week 4

Secondary Outcomes (1)

• efficacy of allergy testing

  Week 4

Study Arms (1)

Experimental

83 adult outpatients at CHR Metz-Thionville with penicillin allergy label

Other: Behavioral allergy testing protocol

Interventions

Behavioral allergy testing protocol OTHER

skin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited during the clinical evaluation of labelled penicillin allergy at the regional hospital of Metz, France (Mercy, Centre Hospitalier Régional CHR de Metz - Thioville). All patients were well and had no need of penicillin treatment at the time of evaluation and testing. A detailed history of the probable implicated molecule, the type of the reaction, the age at onset and the received treatment were obtained by Dr SL.

You may qualify if:

• \- 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz Thionville

Thionville, Moselle, 57100, France

Location

Study Officials

• Sebastien Lefevre, MD

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: May 8, 2019
• Study Start: February 1, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)