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

This study is currently recruiting participants.
Verified December 2013 by University of Milan
Sponsor:
Collaborator:
University of Milano Bicocca
Information provided by (Responsible Party):
Francesco Blasi, University of Milan
ClinicalTrials.gov Identifier:
NCT01492387
First received: December 5, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Pneumonia
Bronchopneumonia
Pleuropneumonia
Pneumonia, Bacterial
Pneumonia, Viral
Other: Discontinuation of antibiotic therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Composite outcome including adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Composite outcome of other adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.

  • Adverse effects [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Costs of care differences between the two study groups based on the total length of hospital stay.


Estimated Enrollment: 892
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492387

Contacts
Contact: Stefano Aliberti, MD 00393394171538 stefano.aliberti@unimib.it
Contact: Francesco Blasi, MD francesco.blasi@unimi.it

Locations
Italy
AO Ospedali Riuniti Bergamo Not yet recruiting
Bergamo, Italy
Contact: Giovanni Michetti, MD       gmichetti@ospedaliriuniti.bergamo.it   
AO Policlinico S. Orsola Malpighi, University of Bologna Recruiting
Bologna, Italy
Contact: Pierluigi Viale, MD       pierluigi.viale@unibo.it   
Principal Investigator: Stefano Nava, MD         
AO S. Anna Recruiting
Como, Italy
Contact: Anna Rosa Maspero, MD       anna.maspero@hsacomo.org   
University of Genoa Not yet recruiting
Genoa, Italy
Contact: Claudio Viscoli, MD       claudio.viscoli@unige.it   
AO C. Poma Not yet recruiting
Mantova, Italy
Contact: Carlo Sturani, MD       carlo.sturani@aopoma.it   
Ospedale Luigi Sacco, University of Milan Recruiting
Milan, Italy
Contact: Nicola Montano, MD       nicola.montano@unimi.it   
Principal Investigator: Fabio Franzetti, MD         
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy
Contact: Francesco Blasi, MD       francesco.blasi@unimi.it   
Sub-Investigator: Roberto Cosentini, MD         
AO San Carlo Borromeo Recruiting
Milan, Italy
Contact: Sandro Amaducci, MD       amaducci.sandro@sancarlo.mi.it   
University of Modena e Reggio Emilia Not yet recruiting
Modena, Italy
Contact: Luca Richeldi, MD       luca.richeldi@unimore.it   
Univeristy of Milano Bicocca Recruiting
Monza, Italy
Contact: Stefano Aliberti, MD       stefano.aliberti@unimib.it   
Principal Investigator: Stefano Aliberti, MD         
Sub-Investigator: Andrea Gori, MD         
IRCCS Policlinico S. Matteo, University of Pavia Not yet recruiting
Pavia, Italy
Contact: Maurizio Luisetti, MD       m.luisetti@smatteo.pv.it   
AO S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Luigi Zucchi, MD       zucchi.luigi@asmn.re.it   
Istituto Clinico Humanitas Not yet recruiting
Rozzano, Italy
Contact: Antonio Voza, MD       antonio.voza@humanitas.it   
IRCCS Policlinico di San Donato Milanese, University of Milan Recruiting
San Donato Milanese, Italy
Contact: Vincenzo Valenti, MD       vincenzo.valenti@unimi.it   
AO S. Maria della Misericordia, Not yet recruiting
Udine, Italy
Contact: Paolo Rossi, MD       rossi.paolo@aoud.sanita.fvg.it   
Principal Investigator: Matteo Bassetti, MD         
Sponsors and Collaborators
University of Milan
University of Milano Bicocca
Investigators
Principal Investigator: Stefano Aliberti, MD University of Milano Bicocca, Milan, Italy
Principal Investigator: Julio A Ramirez, MD University of Louisville, KY, USA
  More Information

Additional Information:
Publications:
Responsible Party: Francesco Blasi, Professor, University of Milan
ClinicalTrials.gov Identifier: NCT01492387     History of Changes
Other Study ID Numbers: DURATION
Study First Received: December 5, 2011
Last Updated: December 31, 2013
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Keywords provided by University of Milan:
community-acquired pneumonia
healthcare-associated pneumonia
antibiotic therapy
Duration of therapy

Additional relevant MeSH terms:
Pneumonia, Bacterial
Bronchopneumonia
Pleuropneumonia
Pneumonia
Pneumonia, Viral
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Pleurisy
Pleural Diseases
Virus Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 21, 2014