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Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams

This study has been completed.
Sponsor:
Collaborator:
Mahidol University
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00789217
First received: November 7, 2008
Last updated: November 26, 2010
Last verified: November 2010
History of Changes
  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
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:

  1. Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
  2. 15-65 years of age

Exclusion Criteria:

  1. On antihistamine/ cannot discontinue antihistamine before the test
  2. Having asthma exacerbation
  3. Being pregnant
  4. 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 by Chulalongkorn University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 May 23, 2013