Cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to -lactams. - ND

• Conditions: allergy; MedDRA version: 9.1Level: LLTClassification code 10013661

• Registration Number: EUCTR2009-017828-54-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-26
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

patients suffering from IgE-mediated allergy to at least one -lactam compound
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the cross-reactivity of ertapenem with other -lactams in patients suffering from IgE-mediated allergy to at least one  -lactam molecule and its tolerability in a group of a patients with negative allergy testing with ertapenem;Secondary Objective: ND;Primary end point(s): to evaluate any allergic reaction