treatment of healthcare-associated pneumonia: a prospective, multicenter study - Treatment of HCAP

Conditions: Pneumonia
MedDRA version: 9.1Level: HLTClassification code 10004048
MedDRA version: 9.1Level: PTClassification code 10060946

Registration Number: EUCTR2009-016476-67-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) patients (age >18 years old) 2) radiological evidence of pneumonia, 2) at least two of the following criteria; fever >38C or hypothermia < 35C, dyspnea, cough and purulent sputum, pleuritic chest pain, or signs of consolidation on respiratory auscultation 3) patients admitted to an acute care hospital for at least 2 days, or underwent surgery, in the 180 days before pneumonia 4) patients who received intravenous chemotherapy in the 30 days before pneumonia; 5) patients who attended a hospital or hemodialysis clinic 6) resided in a nursing home or a long-term care facility
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

Patients with community acquired pneumonia Patients with Hospital acquired pneumonia (onset after >72 h of hospitalization)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To verify if adherence to international recommendations for empirical treatment of healthcare-associated pneumonia (piperacillin/tazobactam OR imipenem/meropenem PLUS vancomycin OR linezolid PLUS ciprofloxacin OPPURE levofloxacin) is associated with a reduction of related in-hospital mortality rate.;Secondary Objective: To verify if adherence to international recommendations for empirical treatment of healthcare-associated pneumonia is associated with a reduction of in-hospital stay.;Primary end point(s): Intra-hospital mortality

Secondary Outcome Measures