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NCT00789217 Clinical Trial

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

Penicillin Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00789217
Other study ID # Chula-ARC 001/08
Secondary ID
Status Completed
Phase N/A
First received November 7, 2008
Last updated November 26, 2010
Start date December 2008
Est. completion date August 2010

Study information
Verified date November 2010
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date August 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Immediate skin test
Intradermal test with immediate reading

Locations
Country Name City State
Thailand Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (2)
Lead Sponsor Collaborator
Chulalongkorn University Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit 1 year Yes
Secondary Clinical correlation and side effects 1 year Yes
Secondary Correlations between Penicillin skin test result with specific IgE and/or basophil activation test 1 year No
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