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

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ClinicalTrials.gov Identifier: NCT00789217
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : November 29, 2010
Sponsor:
Collaborator:
Mahidol University
Information provided by:
Chulalongkorn University

Brief 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.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Procedure: Immediate skin test Not Applicable

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

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 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical correlation and side effects [ Time Frame: 1 year ]
  2. Correlations between Penicillin skin test result with specific IgE and/or basophil activation test [ Time Frame: 1 year ]


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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 11, 2008    Key Record Dates
Last Update Posted: November 29, 2010
Last Verified: November 2010

Keywords provided by Chulalongkorn University:
Penicillin
Beta-Lactams
Allergy
Hypersensitivity

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents