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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01248377
Other study ID # Chula-ARC 002/10
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06406114 - Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing Phase 2