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

NCT02895646 | Unknown

• 1 other identifier: 2012/PHRC/PANGENOMIC/GUEANT/MS
• Study Type: observational
• Target: 2,356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Beta-Lactams Allergy; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family

  day 0

• Severity of allergic reaction

  day 0

• Reactivity to skin test

  day 0

• Serum concentration of specific IgE

  day 0

Study Arms (2)

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.

Other: Collection of blood sample

Control

No specific clinical investigation for control subjects

Other: Collection of blood sample

Interventions

Collection of blood sample OTHER

Beta-lactam antibiotic allergy; Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population having an immediate IgE-mediated hypersensibility to beta-lactam antibiotics and matched control subjects.

You may qualify if:

• 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

You may not qualify if:

• Refusal of participation

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma and DNA

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jean-Louis GUEANT

  Service de BBMNM, CHU Nancy / unité INSERM U954, Faculté de Médecine, 54500 Vandoeuvre Les Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 12, 2016
• Study Start: June 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share