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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017828-54-IT
Enrollment
Unknown
Registered
2010-02-26
Start date
2011-03-28
Completion date
Unknown
Last updated
2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergy MedDRA version: 9.1 Level: LLT Classification code 10013661

Interventions

Trade Name: INVANZ Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Ertapenem Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: pregnancy

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026