Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams - Full Text View

Sponsor:	Chulalongkorn University
Collaborator:	Mahidol University
Information provided by:	Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00789217

Purpose

This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.

Condition	Intervention
Penicillin Allergy	Procedure: Penicillin skin test

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-equivalence Study
Official Title:	The Comparative Results of Penicillin Testing in Patients With History of Allergic Reactions to Betalactams Between Using In-house Penicillin Test Preparation and Commercial Available Penicillin Testing Kit

Resource links provided by NLM:

MedlinePlus related topics: Allergy

Drug Information available for: Penicillins

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:

The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical correlation and side effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Correlations between Penicillin skin test result with specific IgE and/or basophil activation test [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator In-house penicillin testing preparation	Procedure: Penicillin skin test Patients will be tested by in-house penicillin test reagent along with commercial penicillin test reagent
2: Active Comparator Commercial penicillin test kit	Procedure: Penicillin skin test Patients will be tested by commercial penicillin test reagent along with in-house penicillin test reagent
3: Active Comparator Penicillin G Sodium	Procedure: Penicillin skin test Patients will be tested by Penicillin G Sodium along with commercial penicillin test reagent

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
15-65 years of age

Exclusion Criteria:

On antihistamine/ cannot discontinue antihistamine before the test
Having asthma exacerbation
Being pregnant
Suffering from severe systemic disease/ in bad health

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789217

Contacts

Contact: Jettanong Klaewsongkram, MD

662-2564152

jettanong.K@chula.ac.th

Locations

Thailand
Faculty of Medicine, Chulalongkorn University	Recruiting
Bangkok, Thailand, 10330
Contact: Pongsak Wangrattanasopon, MD 662-2564152 w.pongsak@yahoo.co.th
Principal Investigator: Pongsak Wangrattanasopon, MD

Sponsors and Collaborators

Chulalongkorn University

Mahidol University

Investigators

Principal Investigator:

Jettanong Klaewsongkram, MD

Chulalongkorn University

More Information

No publications provided

Responsible Party:	Chulalongkorn University ( Jettanong Klaewsongkram, MD )
Study ID Numbers:	Chula-ARC 001/08
Study First Received:	November 7, 2008
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00789217 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:

Penicillin
Beta-Lactams
Allergy
Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Immune System Diseases
Drug Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010