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

Completed

• Conditions: Non-immediate Drug Reactions; Cephalosporin Allergy
• Interventions: Procedure: Skin tests and ELISPOT assay

• Registration Number: NCT01248377
• Lead Sponsor: Chulalongkorn University

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

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-09
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cephalosporins allergic patients	Skin tests and ELISPOT assay	-

Primary Outcome Measures

Name	Time	Method
The skin testing results of Cephalosporin skin test compared to ELISPOT assay	1 year

Secondary Outcome Measures

Name	Time	Method
The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay	1 year

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand