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Penicillin Allergy Testing and Resensitization Rate

NCT ID: NCT03942731

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-03-15

Brief Summary

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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

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Conditions

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Penicillin Allergy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental

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

Behavioral allergy testing protocol

Intervention Type OTHER

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

Interventions

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Behavioral allergy testing protocol

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien Lefevre, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville

Locations

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CHR Metz Thionville

Thionville, Moselle, France

Site Status

Countries

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France

Other Identifiers

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2019-03Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id