Penicillin AllergyPenicillinNCT03942731
Penicillin Allergy Testing and Resensitization Rate
An observational study of Penicillin Allergy, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Behavioral allergy testing protocol
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 15 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Penicillin Allergy
- Being tested
- Behavioral allergy testing protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral allergy testing protocolOther
skin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 83 adult outpatients at CHR Metz-Thionville with penicillin allergy label Receives: Other: Behavioral allergy testing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of repeated skin testing
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.
Measured: week 4
Secondary outcomes (1)
efficacy of allergy testing
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Feb 2019
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Lefevre, MD, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942731
- Sponsor's protocol ID
- 2019-03Obs-CHRMT
- Acronym
- Penicillin
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.
- ClinicalTrials.gov ID
- NCT03942731
- Acronym / sponsor ID
- Penicillin / 2019-03Obs-CHRMT
- Conditions
- Penicillin Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Behavioral allergy testing protocol83 adult outpatients at CHR Metz-Thionville with penicillin allergy label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 18 years old
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral allergy testing protocolskin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months | Other | Experimental |
Primary outcome
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.
1 secondary outcome
efficacy of allergy testing
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Lefevre, MD principal investigator
CHR Metz Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penicillin Allergy, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of repeated skin testing (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.