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Penicillin Allergy Testing and Resensitization Rate

  • Clinicaltrials.gov identifier

    NCT03942731

  • Recruitment Status

    Completed

  • First Posted

    May 8, 2019

  • Last update posted

    July 31, 2019

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:Penicillin Allergy
  • Intervention/Treatment: Other: Behavioral allergy testing protocol
  • Phase: N/A

Detailed Description

N/A

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: February 2019
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019

Groups and Cohorts

Groups/Cohorts 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 [ Time Frame: 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 [ Time Frame: 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

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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.

Criteria

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

Contacts

Locations

France, Moselle
CHR Metz Thionville
Thionville

Sponsors and Collaborators

Centre Hospitalier Régional Metz-Thionville

Investigators

Principal Investigator: Sebastien Lefevre, MD CHR Metz Thionville

More Information

  • Responsible Party: Centre Hospitalier Régional Metz-Thionville
  • ClinicalTrials.gov Identifier: NCT03942731 History of Changes
  • Other Study ID Numbers: 2019-03Obs-CHRMT
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: July 31, 2019
  • Last Verified: March 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • 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: Drug Hypersensitivity Hypersensitivity