Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics (PANGENOMIC-BL)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Beta-Lactams Allergy; Hypersensitivity

Treatments: Other: Collection of blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT02895646

2012/PHRC/PANGENOMIC/GUEANT/MS

Details and patient eligibility

About

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.

Enrollment: 2,356 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,356 participants in 2 patient groups

Beta-lactam antibiotic allergy

Description:

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.

Treatment:

Other: Collection of blood sample

Control

Description:

No specific clinical investigation for control subjects

Treatment:

Other: Collection of blood sample