Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)
|ClinicalTrials.gov Identifier: NCT01492387|
Recruitment Status : Unknown
Verified December 2013 by Francesco Blasi, University of Milan.
Recruitment status was: Recruiting
First Posted : December 15, 2011
Last Update Posted : January 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Bronchopneumonia Pleuropneumonia Pneumonia, Bacterial Pneumonia, Viral||Other: Discontinuation of antibiotic therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||892 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||March 2015|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492387
|Contact: Stefano Aliberti, MDfirstname.lastname@example.org|
|Contact: Francesco Blasi, MDemail@example.com|
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