Individualizing duration of antibiotic therapy in hospitalized patients with pneumonia

• Conditions: Subjects with diagnosis of pneumonia; MedDRA version: 14.1Level: LLTClassification code 10035739Term: Pneumonia, organism unspecifiedSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-003176-36-IT
• Lead Sponsor: FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 892

Inclusion Criteria

1) Diagnosis of pneumonia
2) Having received an 'adequate empirical antibiotic therapy for pneumonia within 24 hours of admission to hospital.
3) have achieved clinical stability within 5 days of hospitalization, in the absence of changes to the initial empirical antibiotic therapy.
4) Have signed the informed consent
5)> 18 years
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 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion Criteria

1) patients with immune deficiency, defined as: chemotherapy in the previous 12 months, radiotherapy in the previous 12 months, transplantation, immunosuppressive treatment, haematological malignancy, AIDS or HIV infection with CD4 counts <200, asplenia.
2) Patients with other concomitant infection at the time of hospitalization that requires antibiotic treatment.
3) Patients with documented bacteremia with S. aureus.
4) Patients with pneumonia caused by fungi, mycobacteria, or Pneumocystis jiroveci

Study & Design

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