Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)
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.
Other: Discontinuation of antibiotic therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.|
- Composite outcome including adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Composite outcome of other adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Antibiotic exposure [ Time Frame: 90 days ] [ Designated as safety issue: No ]Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
- Adverse effects [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]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.
- Composite outcome of other adverse events at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]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.
- Length of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Costs [ Time Frame: 30 days ] [ Designated as safety issue: No ]Costs of care differences between the two study groups based on the total length of hospital stay.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Local standard of care
Patients randomized to this arm will be treated for the duration of therapy dictated by the primary care physician.
Experimental: Individualized arm
Patients randomized to this 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.
Other: Discontinuation of antibiotic therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492387
|Contact: Stefano Aliberti, MDfirstname.lastname@example.org|
|Contact: Francesco Blasi, MDemail@example.com|
|AO Ospedali Riuniti Bergamo||Not yet recruiting|
|Contact: Giovanni Michetti, MD firstname.lastname@example.org|
|AO Policlinico S. Orsola Malpighi, University of Bologna||Recruiting|
|Contact: Pierluigi Viale, MD email@example.com|
|Principal Investigator: Stefano Nava, MD|
|AO S. Anna||Recruiting|
|Contact: Anna Rosa Maspero, MD firstname.lastname@example.org|
|University of Genoa||Not yet recruiting|
|Contact: Claudio Viscoli, MD email@example.com|
|AO C. Poma||Not yet recruiting|
|Contact: Carlo Sturani, MD firstname.lastname@example.org|
|AO San Carlo Borromeo||Recruiting|
|Contact: Sandro Amaducci, MD email@example.com|
|IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico||Recruiting|
|Contact: Francesco Blasi, MD firstname.lastname@example.org|
|Sub-Investigator: Roberto Cosentini, MD|
|Ospedale Luigi Sacco, University of Milan||Recruiting|
|Contact: Nicola Montano, MD email@example.com|
|Principal Investigator: Fabio Franzetti, MD|
|University of Modena e Reggio Emilia||Not yet recruiting|
|Contact: Luca Richeldi, MD firstname.lastname@example.org|
|Univeristy of Milano Bicocca||Recruiting|
|Contact: Stefano Aliberti, MD email@example.com|
|Principal Investigator: Stefano Aliberti, MD|
|Sub-Investigator: Andrea Gori, MD|
|IRCCS Policlinico S. Matteo, University of Pavia||Not yet recruiting|
|Contact: Maurizio Luisetti, MD firstname.lastname@example.org|
|AO S. Maria Nuova||Recruiting|
|Reggio Emilia, Italy|
|Contact: Luigi Zucchi, MD email@example.com|
|Istituto Clinico Humanitas||Not yet recruiting|
|Contact: Antonio Voza, MD firstname.lastname@example.org|
|IRCCS Policlinico di San Donato Milanese, University of Milan||Recruiting|
|San Donato Milanese, Italy|
|Contact: Vincenzo Valenti, MD email@example.com|
|AO S. Maria della Misericordia,||Not yet recruiting|
|Contact: Paolo Rossi, MD firstname.lastname@example.org|
|Principal Investigator: Matteo Bassetti, MD|
|Principal Investigator:||Stefano Aliberti, MD||University of Milano Bicocca, Milan, Italy|
|Principal Investigator:||Julio A Ramirez, MD||University of Louisville, KY, USA|