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HEALTHCARE ASSOCIATED INFECTIONS IN CIRROTIC PATIENT: RANDOMIZED TRIALOF ANTIBIOTIC THERAPY

HEALTHCARE ASSOCIATED BACTERIAL INFECTIONS IN HOSPITALIZED CIRRHOTIC PATIENTS. RANDOMIZED TRIAL:EMPIRICAL TRADIDIONAL ANTIBIOTIC THERAPY VS SECOND LINE THERAPY

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000173-22-IT
Enrollment
Unknown
Registered
2012-08-27
Start date
2012-07-20
Completion date
Unknown
Last updated
2014-02-03

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

Conditions

Healthcare-associeted bacterial infections in hospitalized cirrhotic patients. MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: TIENAM*EV FL 500MG+500MG 20ML Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: IMIPENEM CAS Number: 64221-86-9 Concentration unit: mg milligram(s) Con

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age (> 18 years) - Written informed consensus Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: - HIV coinfection - Treatment with high doses of corticosteroids o other immunosuppressant drugs

Design outcomes

Primary

MeasureTime frame
Main Objective: Prospectic efficancy evaluation of carbapenem antibiotic treatment ("anti-MDR" therapy) with the association of imipenem and cilastatin in a group of cirrhotic patients with bacterial healtcare-associated infections.;Secondary Objective: Expence due to theraphy, collateral effects of therapy and intrahospedalized mortality.;Primary end point(s): - Complications - Lenght of antibiotic therapy - Hospitalization period - Failure of empiric antibiotic therapy - Intrahospital mortality;Timepoint(s) of evaluation of this end point: 1 month—

Secondary

MeasureTime frame
Secondary end point(s): - Therapy cost - Collateral effects of the therapy;Timepoint(s) of evaluation of this end point: 1 month—

Countries

Italy

Contacts

Public ContactDIPARTIMENTO DI MEDICINA CLINICA

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO PRIMO

manuela.merli@uniroma1.it0649972009

Outcome results

None listed

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