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

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ClinicalTrials.gov Identifier: NCT01248377
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cephalosporin Allergy Non-immediate Drug Reactions Procedure: Skin tests and ELISPOT assay

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

Study Design

Study Type : Observational
Actual Enrollment : 28 participants
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
Study Start Date : June 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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
  • ELISPOT


Outcome Measures

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations

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): NCT01248377


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jettanong Klaewsongkram, Faculty of Medicine, Department of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01248377     History of Changes
Other Study ID Numbers: Chula-ARC 002/10
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Jettanong Klaewsongkram, Chulalongkorn University:
Cephalosporins
Drug hypersensitivity

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents