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

November 26, 2010 updated by: Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Intradermal test with reading at 15 minutes after injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Mahidol University

Investigators

  • Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chula-ARC 001/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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