Penicillin Allergy Testing and Resensitization Rate

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Completed
CT.gov ID
NCT03942731
Collaborator
(none)
83
1
1.4
60.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Behavioral allergy testing protocol

Study Design

Study Type:
Observational
Actual Enrollment :
83 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHR Metz Thionville Thionville Moselle France 57100

Sponsors and Collaborators

  • Centre Hospitalier Régional Metz-Thionville

Investigators

  • Principal Investigator: Sebastien Lefevre, MD, CHR Metz Thionville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier:
NCT03942731
Other Study ID Numbers:
  • 2019-03Obs-CHRMT
First Posted:
May 8, 2019
Last Update Posted:
Jul 31, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 31, 2019