Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins

NCT ID: NCT01248377

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins

Detailed Description

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Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay

Conditions

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Cephalosporin Allergy Non-immediate Drug Reactions

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cephalosporins allergic patients

Skin tests and ELISPOT assay

Intervention Type PROCEDURE

Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay

Interventions

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Skin tests and ELISPOT assay

Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay

Intervention Type PROCEDURE

Other Intervention Names

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Patch test Intradermal test ELISPOT

Eligibility Criteria

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Inclusion Criteria

1. Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
2. At least 18 years of age

Exclusion Criteria

1. Suffering from severe systemic disease/ in bad health
2. Being pregnant
3. Patients with a history of immediate reactions to cephalosporin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Jettanong Klaewsongkram

Faculty of Medicine, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jettanong Klaewsongkram, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzyme-linked immunospot to diagnose cephalosporin-induced maculopapular exanthems. Acta Derm Venereol. 2013 Jan;93(1):66-9. doi: 10.2340/00015555-1386.

Reference Type DERIVED
PMID: 22722755 (View on PubMed)

Other Identifiers

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Chula-ARC 002/10

Identifier Type: -

Identifier Source: org_study_id