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

This study has been completed.
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University Identifier:
First received: November 24, 2010
Last updated: October 9, 2011
Last verified: October 2011
This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins

Condition Intervention
Cephalosporin Allergy
Non-immediate Drug Reactions
Procedure: Skin tests and ELISPOT assay

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Results of Skin Testing and The Detection of Cytokine Secretion From Drug Specific Peripheral Blood Mononuclear Cells Using ELISPOT Assay in the Diagnosis of Nonimmediate Reactions to Cephalosporins

Resource links provided by NLM:

Further study details as provided by Jettanong Klaewsongkram, Chulalongkorn University:

Primary Outcome Measures:
  • The skin testing results of Cephalosporin skin test compared to ELISPOT assay [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
PBMCs and serum will be collected for further analysis, if indicated

Enrollment: 28
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cephalosporins allergic patients Procedure: 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
Other Names:
  • Patch test
  • Intradermal test

Detailed Description:
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins

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
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Please refer to this study by its identifier: NCT01248377

Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jettanong Klaewsongkram, Faculty of Medicine, Department of Medicine, Chulalongkorn University Identifier: NCT01248377     History of Changes
Other Study ID Numbers: Chula-ARC 002/10
Study First Received: November 24, 2010
Last Updated: October 9, 2011

Keywords provided by Jettanong Klaewsongkram, Chulalongkorn University:
Drug hypersensitivity

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017