The purpose of the study is to assess the efficacy of an individualized approach to duration of antibiotic therapy based on each subject's clinical response compared to a local standard approach in patients coming from the community and who are hospitalized because of a pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
892
Patients randomized in the Individualized Arm will be treated according to clinical response: antibiotic therapy will be discontinued 48 hours after the day that the patient reaches clinical stability, with at least 5 days of total antibiotic treatment.
AO Ospedali Riuniti Bergamo
Bergamo, Italy
NOT_YET_RECRUITINGAO Policlinico S. Orsola Malpighi, University of Bologna
Bologna, Italy
Composite outcome including adverse events
Any among the following: 1) disease-specific complications due to pneumonia, such as lung abscess, empyema, meningitis, endocarditis, arthritis or pericarditis; 2) clinical failure during hospitalization (either hemodynamic or respiratory failure); 3) a new course of antibiotics (at least one dose), after discontinuation of antibiotic therapy given for the pneumonia, either endovenous or oral; 4) re-hospitalization; 5) death.
Time frame: 30 days
Composite outcome of other adverse events
Any among the following: 1) disease-specific complications due to pneumonia, such as lung abscess, empyema, meningitis, endocarditis, arthritis or pericarditis; 2) clinical failure due to pneumonia occurring during hospitalization (either hemodynamic or respiratory failure); 3) a new course of antibiotics (at least one dose), after discontinuation of antibiotic therapy given for the pneumonia, either endovenous or oral, for a relapse of pneumonia; 4) re-hospitalization due to a relapse of pneumonia; 5) death due to pneumonia.
Time frame: 30 days
Antibiotic exposure
Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
Time frame: 90 days
Adverse effects
Adverse effects will include: anaphylactic reactions and allergic skin reactions; Clostridium difficile-associated colitis; hematologic toxicity; hepatotoxicity; convulsions; tendinopathies; peripheral neuropathy; prolongation of the QTc interval; nausea; diarrhea; vomiting; abdominal pain; nephrotoxicity.
Time frame: 90 days
Composite outcome of other adverse events at 90 days
Any among the following: 1) a new course of antibiotics for any reason after discontinuation of antibiotic therapy for pneumonia; 2) re-hospitalization for any reason; 3) death from any reason.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AO S. Anna
Como, Italy
RECRUITINGUniversity of Genoa
Genoa, Italy
NOT_YET_RECRUITINGAO C. Poma
Mantova, Italy
NOT_YET_RECRUITINGAO San Carlo Borromeo
Milan, Italy
RECRUITINGIRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
RECRUITINGOspedale Luigi Sacco, University of Milan
Milan, Italy
RECRUITINGUniversity of Modena e Reggio Emilia
Modena, Italy
NOT_YET_RECRUITINGUniveristy of Milano Bicocca
Monza, Italy
RECRUITING...and 5 more locations
Time frame: 90 days
Length of hospitalization
Number of days from the date of admission to the hospital to either the date of discharge (patients sent home or to a long-term care facility) or the date of death if occurred during hospitalization.
Time frame: 30 days
Costs
Costs of care differences between the two study groups based on the total length of hospital stay.
Time frame: 30 days