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Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics

Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02895646
Acronym
PANGENOMIC-BL
Enrollment
2356
Registered
2016-09-12
Start date
2012-06-30
Completion date
2017-06-30
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-Lactams Allergy, Hypersensitivity

Brief 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. 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.

Interventions

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Refusal of participation

Design outcomes

Primary

MeasureTime frameDescription
Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergyday 0Common (\>10%) or rare (1-10%) genetic polymorphisms in patients with beta-lactam immediate allergy

Secondary

MeasureTime frameDescription
Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same familyday 0Allelic 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
Severity of allergic reactionday 0evaluated during clinical examination
Reactivity to skin testday 0
Serum concentration of specific IgEday 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026