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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014