Beta-Lactams AllergyPANGENOMIC-BLNCT02895646
Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
An observational study of Beta-Lactams Allergy and Hypersensitivity, run by Central Hospital, Nancy, France.
Trial summary
Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Beta-Lactams Allergy, Hypersensitivity
- What is being tested?
- Collection of blood sample
- How many people
- 2,356 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population having an immediate IgE-mediated hypersensibility to beta-lactam antibiotics and matched control subjects.
Who may be able to join
- Informed consent
- Allergy group: Immediate allergic reaction (less than 2 hours after drug administration) to an antibiotic of penicillin or cephalosporin groups
- Allergy group: Positive skin test (intradermal test) with a non-irritant dilution of antibiotic of penicillin or cephalosporin groups
Who cannot join
- Refusal of participation
About this study
Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin, revealed by studies in groups of different ethnical origins in the same geographical region. There are also some families with a high frequency of allergic reactions without identified Mendelian inheritance.
The purpose of this study is to identify predictive risk factors associated to immediate allergic reactions against beta-lactam antibiotics with a pangenomic approach.
A secondary purpose is to identify rare predictive factors with homozygosity mapping and exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.
- Conditions
- Beta-Lactams Allergy, Hypersensitivity
- Being tested
- Collection of blood sample
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Beta-lactam antibiotic allergy | Diagnosis based on clinical symptomatology and skin test positive for allergen and negative for other drugs and substances. Skin tests are performed 6 weeks after allergic reaction. Receives: Other: Collection of blood sample | |
| Control | No specific clinical investigation for control subjects Receives: Other: Collection of blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy
Common (>10%) or rare (1-10%) genetic polymorphisms in patients with beta-lactam immediate allergy
Measured: day 0
Secondary outcomes (4)
Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family
Allelic homozygosity in one or more regions of genome with one or more genes involved in allergen response, in more than 2 individuals affected by beta-lactam allergy in the same family
Measured: day 0
Severity of allergic reaction
evaluated during clinical examination
Measured: day 0
Reactivity to skin test
Measured: day 0
Serum concentration of specific IgE
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-Lactams AllergyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis GUEANT, Principal investigator, Service de BBMNM, CHU Nancy / unité INSERM U954, Faculté de Médecine, 54500 Vandoeuvre Les Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895646
- Sponsor's protocol ID
- 2012/PHRC/PANGENOMIC/GUEANT/MS
- Acronym
- PANGENOMIC-BL
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
- ClinicalTrials.gov ID
- NCT02895646
- Acronym / sponsor ID
- PANGENOMIC-BL / 2012/PHRC/PANGENOMIC/GUEANT/MS
- Conditions
- Beta-Lactams Allergy, Hypersensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,356 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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.
Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin, revealed by studies in groups of different ethnical origins in the same geographical region. There are also some families with a high frequency of allergic reactions without identified Mendelian inheritance.
The purpose of this study is to identify predictive risk factors associated to immediate allergic reactions against beta-lactam antibiotics with a pangenomic approach.
A secondary purpose is to identify rare predictive factors with homozygosity mapping and exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-lactam antibiotic allergy | – | Other: Collection of blood sampleDiagnosis based on clinical symptomatology and skin test positive for allergen and negative for other drugs and substances. Skin tests are performed 6 weeks after allergic reaction. |
| Control | – | Other: Collection of blood sampleNo specific clinical investigation for control subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population having an immediate IgE-mediated hypersensibility to beta-lactam antibiotics and matched control subjects.
Key inclusion criteria (3 listed)
- Informed consent
- Allergy group: Immediate allergic reaction (less than 2 hours after drug administration) to an antibiotic of penicillin or cephalosporin groups
- Allergy group: Positive skin test (intradermal test) with a non-irritant dilution of antibiotic of penicillin or cephalosporin groups
Key exclusion criteria (1 listed)
- Refusal of participation
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 |
|---|---|---|
| Collection of blood sample | Other | Beta-lactam antibiotic allergy, Control |
Primary outcome
Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy
Time frame: day 0
Common (>10%) or rare (1-10%) genetic polymorphisms in patients with beta-lactam immediate allergy
4 secondary outcomes
Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family
Time frame: day 0
Severity of allergic reaction
Time frame: day 0
Reactivity to skin test
Time frame: day 0
Serum concentration of specific IgE
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Individual participant dataSharing planned: No
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Allergy
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.
Jean-Louis GUEANT principal investigator
Service de BBMNM, CHU Nancy / unité INSERM U954, Faculté de Médecine, 54500 Vandoeuvre Les Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Beta-Lactams Allergy and Hypersensitivity, run by Central Hospital, Nancy, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy (time frame: day 0). 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 3 Feb 2017.