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 ]

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.


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