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

December 31, 2013 updated by: Francesco Blasi, University of Milan

Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

892

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bergamo, Italy
      • Bologna, Italy
        • Recruiting
        • AO Policlinico S. Orsola Malpighi, University of Bologna
      • Como, Italy
      • Genoa, Italy
      • Mantova, Italy
      • Milan, Italy
      • Milan, Italy
        • Recruiting
        • IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
        • Contact:
        • Sub-Investigator:
          • Roberto Cosentini, MD
      • Milan, Italy
        • Recruiting
        • Ospedale Luigi Sacco, University of Milan
        • Contact:
        • Principal Investigator:
          • Fabio Franzetti, MD
      • Modena, Italy
      • Monza, Italy
        • Recruiting
        • Univeristy of Milano Bicocca
        • Contact:
        • Principal Investigator:
          • Stefano Aliberti, MD
        • Sub-Investigator:
          • Andrea Gori, MD
      • Pavia, Italy
        • Not yet recruiting
        • IRCCS Policlinico S. Matteo, University of Pavia
        • Contact:
      • Reggio Emilia, Italy
      • Rozzano, Italy
      • San Donato Milanese, Italy
        • Recruiting
        • IRCCS Policlinico di San Donato Milanese, University of Milan
        • Contact:
      • Udine, Italy
        • Not yet recruiting
        • AO S. Maria della Misericordia,
        • Contact:
        • Principal Investigator:
          • Matteo Bassetti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
Antibiotic exposure
Time Frame: 90 days
Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
90 days
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.
90 days
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.
90 days
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.
30 days
Costs
Time Frame: 30 days
Costs of care differences between the two study groups based on the total length of hospital stay.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stefano Aliberti, MD, University of Milano Bicocca, Milan, Italy
  • Principal Investigator: Julio A Ramirez, MD, University of Louisville, KY, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (ESTIMATE)

December 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 3, 2014

Last Update Submitted That Met QC Criteria

December 31, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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