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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.
Sponsor:
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01248377
First received: November 24, 2010
Last updated: October 9, 2011
Last verified: October 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

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

Secondary Outcome Measures:
  • The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
  • ELISPOT

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Chulalongkorn University

Additional 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
Study First Received: November 24, 2010
Last Updated: October 9, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Cephalosporins
Drug hypersensitivity

Additional relevant MeSH terms:
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013