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Penicillin Allergy Testing and Resensitization Rate (Penicillin)

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ClinicalTrials.gov Identifier: NCT03942731
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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
Penicillin Allergy Other: Behavioral allergy testing protocol

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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 1, 2019
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

Group/Cohort 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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942731


Locations
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France
CHR Metz Thionville
Thionville, Moselle, France, 57100
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
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Principal Investigator: Sebastien Lefevre, MD CHR Metz Thionville

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents