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

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ClinicalTrials.gov Identifier: NCT02895646
Recruitment Status : Unknown
Verified September 2016 by Central Hospital, Nancy, France.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2016
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment
Beta-Lactams Allergy Hypersensitivity Other: Collection of blood sample

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Study Type : Observational
Actual Enrollment : 2356 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Antibiotics

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family [ Time Frame: day 0 ]
    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

  2. Severity of allergic reaction [ Time Frame: day 0 ]
    evaluated during clinical examination

  3. Reactivity to skin test [ Time Frame: day 0 ]
  4. Serum concentration of specific IgE [ Time Frame: day 0 ]

Biospecimen Retention:   Samples With DNA
Serum, plasma and DNA


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Population having an immediate IgE-mediated hypersensibility to beta-lactam antibiotics and matched control subjects.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895646


Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Jean-Louis GUEANT Service de BBMNM, CHU Nancy / unité INSERM U954, Faculté de Médecine, 54500 Vandoeuvre Les Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02895646     History of Changes
Other Study ID Numbers: 2012/PHRC/PANGENOMIC/GUEANT/MS
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Anti-Bacterial Agents
Lactams
beta-Lactams
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents