Skin Testing and ELISPOT Assay in Patients With a History... | NCT01248377

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

NCT01248377

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Oct 12, 2011Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Cephalosporin Allergy
Non-immediate Drug Reactions

Interventions

Skin tests and ELISPOT assay

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Nov 24, 2010

First Submission Date that Met QC Criteria

Nov 24, 2010

First Posted Date

Nov 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2011

Last Update Posted Date

Oct 12, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jettanong Klaewsongkram, Faculty of Medicine, Department of Medicine, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cephalosporins allergic patients			Procedure: Skin tests and ELISPOT assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin tests and ELISPOT assay	Procedure	Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The skin testing results of Cephalosporin skin test compared to ELISPOT assay		1 year

Secondary Outcomes

Measure	Description	Time Frame
The result of cross reactivity between Cephalosporins and other Betalactams determined by skin testing and ELISPOT assay		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
At least 18 years of age

Exclusion Criteria:

Suffering from severe systemic disease/ in bad health
Being pregnant
Patients with a history of immediate reactions to cephalosporin

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with a history of non-immediate hypersensitivity reactions to cephalosporins

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jettanong Klaewsongkram, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22722755	Derived	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.

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

ID	Term
D012882	Skin Tests
D010328	Patch Tests
D007428	Intradermal Tests
D058501	Enzyme-Linked Immunospot Assay

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis