Status:

UNKNOWN

Safety of Ertapenem in Beta-lactam Allergic Patients.

Lead Sponsor:

Catholic University of the Sacred Heart

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Conditions:

IgE-Mediated Hypersensitivity

Allergy

Eligibility:

All Genders

16-75 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.

Detailed Description

Ertapenem is a new carbapenem, stable to dehydropeptidase which has a broad antibacterial activity. Ertapenem exhibits a bactericidal mode of action and it has a long half-life of 4.5 hours; for this ...

Eligibility Criteria

Inclusion

  • IgE-mediated allergy to at least one beta-lactam molecule

Exclusion

  • positive allergy testing to ertapenem
  • chronic diseases
  • treatment with beta-blockers
  • pregnancy

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2011

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01159379

Start Date

January 1 2011

End Date

December 1 2011

Last Update

January 5 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Allergy Department, Catholic University of the Sacred Heart

Rome, Italy, 00168