NCT00789217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 29, 2010

Status Verified

November 1, 2010

Enrollment Period

1.2 years

First QC Date

November 7, 2008

Last Update Submit

November 26, 2010

Conditions

Keywords

PenicillinBeta-LactamsAllergyHypersensitivity

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (2)

  • Clinical correlation and side effects

    1 year

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

    1 year

Study Arms (3)

In-house penicillin testing preparation

ACTIVE COMPARATOR

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

Procedure: Immediate skin test

Commercial penicillin test kit

ACTIVE COMPARATOR

Commercial penicillin test kit order from Diater company

Procedure: Immediate skin test

Penicillin G Sodium

ACTIVE COMPARATOR

Penicillin G Sodium from routine clinical use

Procedure: Immediate skin test

Interventions

Intradermal test with immediate reading

Also known as: Intradermal test with reading at 15 minutes after injection
Commercial penicillin test kitIn-house penicillin testing preparationPenicillin G Sodium

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypersensitivity

Interventions

Intradermal Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Jettanong Klaewsongkram, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 11, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2010

Study Completion

August 1, 2010

Last Updated

November 29, 2010

Record last verified: 2010-11

Locations