Penicillin Allergy Testing and Resensitization Rate

Penicillin Allergy Clinical Trial

— Penicillin  

Official title:

Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942731
• Other study ID #: 2019-03Obs-CHRMT
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity
• Penicillin Allergy

Intervention

Other:
• Behavioral allergy testing protocol
skin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months

Locations

Country	Name	City	State
France	CHR Metz Thionville	Thionville	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	efficacy of allergy testing	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.	Week 4