- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942731
Penicillin Allergy Testing and Resensitization Rate (Penicillin)
July 30, 2019 updated by: Centre Hospitalier Régional Metz-Thionville
Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
83
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Moselle
-
Thionville, Moselle, France, 57100
- CHR Metz Thionville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental
83 adult outpatients at CHR Metz-Thionville with penicillin allergy label
|
skin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sebastien Lefevre, MD, CHR Metz Thionville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
March 15, 2019
Study Completion (Actual)
March 15, 2019
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-03Obs-CHRMT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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