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

Cephalosporin Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248377
• Other study ID #: Chula-ARC 002/10
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: October 9, 2011
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cephalosporin Allergy
• Drug-Related Side Effects and Adverse Reactions
• Non-immediate Drug Reactions

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The skin testing results of Cephalosporin skin test compared to ELISPOT assay		1 year	Yes
Secondary	The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay		1 year	No