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

Hypersensitivity Clinical Trial

— PANGENOMIC-BL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02895646
• Other study ID #: 2012/PHRC/PANGENOMIC/GUEANT/MS
• Status: Active, not recruiting
• Phase: N/A
• First received: September 5, 2016
• Last updated: February 2, 2017
• Start date: June 2012
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2356
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Beta-Lactams Allergy
• Hypersensitivity

Intervention

Other:
• Collection of blood sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 0
Secondary	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	day 0
Secondary	Severity of allergic reaction	evaluated during clinical examination	day 0
Secondary	Reactivity to skin test		day 0
Secondary	Serum concentration of specific IgE		day 0