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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

Detailed Description

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

Interventions

  • Procedure: Immediate skin test
    • Intradermal test with immediate reading

Arms, Groups and Cohorts

  • Active Comparator: In-house penicillin testing preparation
    • In-house penicillin testing prepared from alkali-treated penicillin G
  • Active Comparator: Commercial penicillin test kit
    • Commercial penicillin test kit order from Diater company
  • Active Comparator: Penicillin G Sodium
    • Penicillin G Sodium from routine clinical use

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

  • Clinical correlation and side effects
    • Time Frame: 1 year
  • Correlations between Penicillin skin test result with specific IgE and/or basophil activation test
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chulalongkorn University
  • Collaborator
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Jettanong Klaewsongkram, MD, Chulalongkorn University
  • Overall Official(s)
    • Jettanong Klaewsongkram, MD, Principal Investigator, Chulalongkorn University

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