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: Immediate skin test

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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: Penicillin G Penicillin G Sodium Penicillin G Benzathine Penicillin G Potassium 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 ]

Enrollment:	63
Study Start Date:	December 2008
Study Completion Date:	August 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: In-house penicillin testing preparation In-house penicillin testing prepared from alkali-treated penicillin G	Procedure: Immediate skin test Intradermal test with immediate reading Other Name: Intradermal test with reading at 15 minutes after injection
Active Comparator: Commercial penicillin test kit Commercial penicillin test kit order from Diater company	Procedure: Immediate skin test Intradermal test with immediate reading Other Name: Intradermal test with reading at 15 minutes after injection
Active Comparator: Penicillin G Sodium Penicillin G Sodium from routine clinical use	Procedure: Immediate skin test Intradermal test with immediate reading Other Name: Intradermal test with reading at 15 minutes after injection

Detailed Description:

The results of skin test with immediate reading will be compared between alkali-treated penicillin G and DAP reagents from Diater

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

Locations

Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330

Sponsors and Collaborators

Chulalongkorn University

Mahidol University

Investigators

Principal Investigator:

Jettanong Klaewsongkram, MD

Chulalongkorn University

More Information

No publications provided

Responsible Party:	Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier:	NCT00789217 History of Changes
Other Study ID Numbers:	Chula-ARC 001/08
Study First Received:	November 7, 2008
Last Updated:	November 26, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:

Penicillin
Beta-Lactams
Allergy
Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine

Beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012