Clinical Trial: Duration of Antibiotic Therapy in Community - Acquired Pneumonia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.
Brief Summary: 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.
Detailed Summary:
Sponsor: University of Milan
Current Primary Outcome: Composite outcome including adverse events [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Composite outcome of other adverse events [ Time Frame: 30 days ]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 ]Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
- Adverse effects [ Time Frame: 90 days ]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 ]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 ]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 ]Costs of care differences between the two study groups based on the total length of hospital stay.
Original Secondary Outcome: Same as current
Information By: University of Milan
Dates:
Date Received: December 5, 2011
Date Started: January 2012
Date Completion: March 2015
Last Updated: December 31, 2013
Last Verified: December 2013