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

Primary Purpose

Penicillin Allergy

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Immediate skin test

About this trial

This is an interventional diagnostic trial for Penicillin Allergy focused on measuring Penicillin, Beta-Lactams, Allergy, Hypersensitivity

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins
15-65 years of age

Exclusion Criteria:

On antihistamine/ cannot discontinue antihistamine before the test
Having asthma exacerbation
Being pregnant
Suffering from severe systemic disease/ in bad health

Sites / Locations

Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

In-house penicillin testing preparation

Commercial penicillin test kit

Penicillin G Sodium

Arm Description

In-house penicillin testing prepared from alkali-treated penicillin G

Commercial penicillin test kit order from Diater company

Penicillin G Sodium from routine clinical use

Outcomes

Primary Outcome Measures

The skin testing results of in-house penicillin skin test and Penicillin G Sodium compared to commercial penicillin testing kit

Secondary Outcome Measures

Clinical correlation and side effects

Correlations between Penicillin skin test result with specific IgE and/or basophil activation test

Full Information

NCT ID

NCT00789217

First Posted

November 7, 2008

Last Updated

November 26, 2010

Sponsor

Chulalongkorn University

Collaborators

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00789217

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chulalongkorn University

Collaborators

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Penicillin Allergy

Keywords

Penicillin, Beta-Lactams, Allergy, Hypersensitivity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

In-house penicillin testing preparation

Arm Type

Active Comparator

Arm Description

In-house penicillin testing prepared from alkali-treated penicillin G

Arm Title

Commercial penicillin test kit

Arm Type

Active Comparator

Arm Description

Commercial penicillin test kit order from Diater company

Arm Title

Penicillin G Sodium

Arm Type

Active Comparator

Arm Description

Penicillin G Sodium from routine clinical use

Intervention Type

Procedure

Intervention Name(s)

Immediate skin test

Other Intervention Name(s)

Intradermal test with reading at 15 minutes after injection

Intervention Description

Intradermal test with immediate reading

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Clinical correlation and side effects

Time Frame

1 year

Title

Correlations between Penicillin skin test result with specific IgE and/or basophil activation test

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with history of hypersensitivity reactions to betalactams; penicillin, aminopenicillins, and cephalosporins 15-65 years of age Exclusion Criteria: On antihistamine/ cannot discontinue antihistamine before the test Having asthma exacerbation Being pregnant Suffering from severe systemic disease/ in bad health

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jettanong Klaewsongkram, MD

Organizational Affiliation

Chulalongkorn University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine, Chulalongkorn University

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

22525392

Citation

Wangrattanasopon P, Ruxrungtham K, Chantaphakul H, Buranapraditkun S, Klaewsongkram J. Alkali-treated penicillin G solution is a better option than penicillin G as an alternative source of minor determinants for penicillin skin test. Allergy Asthma Proc. 2012 Mar-Apr;33(2):152-9. doi: 10.2500/aap.2012.33.3496.

Results Reference

derived

Learn more about this trial

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

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