Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins
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
1 other identifier
observational
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 24, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedOctober 12, 2011
October 1, 2011
11 months
November 24, 2010
October 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The skin testing results of Cephalosporin skin test compared to ELISPOT assay
1 year
Secondary Outcomes (1)
The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay
1 year
Study Arms (1)
Cephalosporins allergic patients
Interventions
Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay
Eligibility Criteria
Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins
You may qualify if:
- Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
- At least 18 years of age
You may not qualify if:
- Suffering from severe systemic disease/ in bad health
- Being pregnant
- Patients with a history of immediate reactions to cephalosporin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
Related Publications (1)
Tanvarasethee B, Buranapraditkun S, Klaewsongkram J. The potential of using enzyme-linked immunospot to diagnose cephalosporin-induced maculopapular exanthems. Acta Derm Venereol. 2013 Jan;93(1):66-9. doi: 10.2340/00015555-1386.
PMID: 22722755DERIVED
Biospecimen
PBMCs and serum will be collected for further analysis, if indicated
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jettanong Klaewsongkram, MD
Chulalongkorn University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Medicine, Department of Medicine
Study Record Dates
First Submitted
November 24, 2010
First Posted
November 25, 2010
Study Start
June 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10