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Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)

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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
Sponsor:
Collaborator:
University of Milano Bicocca
Information provided by (Responsible Party):
Francesco Blasi, University of Milan

Tracking Information
First Submitted Date  ICMJE December 5, 2011
First Posted Date  ICMJE December 15, 2011
Last Update Posted Date January 3, 2014
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01492387 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duration of Antibiotic Therapy in Community - Acquired Pneumonia
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pneumonia
  • Bronchopneumonia
  • Pleuropneumonia
  • Pneumonia, Bacterial
  • Pneumonia, Viral
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Discontinuation of antibiotic therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 14, 2011)
892
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients will be 18 years old or older and meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  1. Diagnosis of pneumonia:

    Evidence of a new pulmonary infiltrate seen on either radiograph or computed tomography of the chest within 48 hours after hospitalization plus at least two among the following: 1) new or increased cough with/without sputum production and/or purulent respiratory secretions; 2) fever (documented temperature -rectal or oral- ≥ 37.8 °C) or hypothermia (documented temperature -rectal or oral- <36o C); 3) deterioration of oxygenation; 4) evidence of systemic inflammation (such as abnormal white blood cell count -either leukocytosis (>10,000/cm3) or leukopenia (< 4,000/cm3) - or increasing of C-reactive protein or procalcitonin values above the local upper limit.

    CAP will be defined as pneumonia occurring in any patient admitted to the hospital coming from the community and who were not hospitalized in the previous 14 days. HCAP will be defined as a community-acquired pneumonia occurring in a patient with any of the following special epidemiological characteristics: patient who was hospitalized for 2 days or more in the previous 90 days; patient coming from a nursing home or extended care facility; patient who received home infusion therapy (including antibiotics) or wound care in the previous 30 days; patient who was on chronic dialysis in the previous 30 days.

  2. An appropriate empiric antibiotic therapy for the pneumonia received within 24 hours after admission to the hospital.
  3. A clinical stability reached within 5 days after hospital admission, in the absence of any changes of the initial empiric antibiotic therapy.
  4. Signed informed consent

Exclusion Criteria:

Patients presenting with any of the following will not be included in the trial:

  1. Patients with immunodeficiency, defined as: chemotherapy in the previous 12 months, radiotherapy in the previous 12 months, transplantation, immunosuppressive treatment, hematologic malignancy, AIDS or HIV with CD4 count < 200, asplenia.
  2. Patients with a concomitant infection on admission to the hospital requiring antibiotic therapy (i.e urinary tract infection). The presence of sepsis due to pneumonia will not be considered another concomitant infection.
  3. Patients with documented bacteremia due to S. aureus in a blood culture (both methicillin resistant and susceptible S. aureus)
  4. Patients with etiology of pneumonia due to fungi, mycobacterium or Pneumocystis jiroveci.
  5. Patients hospitalized in the previous 15 days

Inclusion and exclusion criteria for the proposed study will not limit the study cohort on the basis of sex, ethnicity, socioeconomic status or other potentially discriminatory factors.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492387
Other Study ID Numbers  ICMJE DURATION
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Blasi, University of Milan
Study Sponsor  ICMJE University of Milan
Collaborators  ICMJE University of Milano Bicocca
Investigators  ICMJE
Principal Investigator: Stefano Aliberti, MD University of Milano Bicocca, Milan, Italy
Principal Investigator: Julio A Ramirez, MD University of Louisville, KY, USA
PRS Account University of Milan
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP