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

Primary Purpose

Pneumonia, Bronchopneumonia, Pleuropneumonia

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Discontinuation of antibiotic therapy
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring community-acquired pneumonia, healthcare-associated pneumonia, antibiotic therapy, Duration of therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AO Ospedali Riuniti Bergamo
  • AO Policlinico S. Orsola Malpighi, University of BolognaRecruiting
  • AO S. AnnaRecruiting
  • University of Genoa
  • AO C. Poma
  • AO San Carlo BorromeoRecruiting
  • IRCCS Fondazione Cà Granda Ospedale Maggiore PoliclinicoRecruiting
  • Ospedale Luigi Sacco, University of MilanRecruiting
  • University of Modena e Reggio Emilia
  • Univeristy of Milano BicoccaRecruiting
  • IRCCS Policlinico S. Matteo, University of Pavia
  • AO S. Maria NuovaRecruiting
  • Istituto Clinico Humanitas
  • IRCCS Policlinico di San Donato Milanese, University of MilanRecruiting
  • AO S. Maria della Misericordia,

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Local standard of care

Individualized arm

Arm Description

Patients randomized to this arm will be treated for the duration of therapy dictated by the primary care physician.

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.

Outcomes

Primary Outcome Measures

Composite outcome including adverse events
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
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
Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
Adverse effects
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
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
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
Costs of care differences between the two study groups based on the total length of hospital stay.

Full Information

First Posted
December 5, 2011
Last Updated
December 31, 2013
Sponsor
University of Milan
Collaborators
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT01492387
Brief Title
Duration of Antibiotic Therapy in Community - Acquired Pneumonia
Acronym
DURATION
Official Title
Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
Collaborators
University of Milano Bicocca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bronchopneumonia, Pleuropneumonia, Pneumonia, Bacterial, Pneumonia, Viral
Keywords
community-acquired pneumonia, healthcare-associated pneumonia, antibiotic therapy, Duration of therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
892 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local standard of care
Arm Type
No Intervention
Arm Description
Patients randomized to this arm will be treated for the duration of therapy dictated by the primary care physician.
Arm Title
Individualized arm
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Discontinuation of antibiotic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite outcome including adverse events
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite outcome of other adverse events
Description
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.
Time Frame
30 days
Title
Antibiotic exposure
Description
Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
Time Frame
90 days
Title
Adverse effects
Description
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.
Time Frame
90 days
Title
Composite outcome of other adverse events at 90 days
Description
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.
Time Frame
90 days
Title
Length of hospitalization
Description
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.
Time Frame
30 days
Title
Costs
Description
Costs of care differences between the two study groups based on the total length of hospital stay.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. An appropriate empiric antibiotic therapy for the pneumonia received within 24 hours after admission to the hospital. A clinical stability reached within 5 days after hospital admission, in the absence of any changes of the initial empiric antibiotic therapy. Signed informed consent Exclusion Criteria: Patients presenting with any of the following will not be included in the trial: 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. 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. Patients with documented bacteremia due to S. aureus in a blood culture (both methicillin resistant and susceptible S. aureus) Patients with etiology of pneumonia due to fungi, mycobacterium or Pneumocystis jiroveci. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Aliberti, MD
Phone
00393394171538
Email
stefano.aliberti@unimib.it
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Blasi, MD
Email
francesco.blasi@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Aliberti, MD
Organizational Affiliation
University of Milano Bicocca, Milan, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio A Ramirez, MD
Organizational Affiliation
University of Louisville, KY, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
AO Ospedali Riuniti Bergamo
City
Bergamo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Michetti, MD
Email
gmichetti@ospedaliriuniti.bergamo.it
Facility Name
AO Policlinico S. Orsola Malpighi, University of Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierluigi Viale, MD
Email
pierluigi.viale@unibo.it
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Facility Name
AO S. Anna
City
Como
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Rosa Maspero, MD
Email
anna.maspero@hsacomo.org
Facility Name
University of Genoa
City
Genoa
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Viscoli, MD
Email
claudio.viscoli@unige.it
Facility Name
AO C. Poma
City
Mantova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Sturani, MD
Email
carlo.sturani@aopoma.it
Facility Name
AO San Carlo Borromeo
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Amaducci, MD
Email
amaducci.sandro@sancarlo.mi.it
Facility Name
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Blasi, MD
Email
francesco.blasi@unimi.it
First Name & Middle Initial & Last Name & Degree
Roberto Cosentini, MD
Facility Name
Ospedale Luigi Sacco, University of Milan
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Montano, MD
Email
nicola.montano@unimi.it
First Name & Middle Initial & Last Name & Degree
Fabio Franzetti, MD
Facility Name
University of Modena e Reggio Emilia
City
Modena
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Richeldi, MD
Email
luca.richeldi@unimore.it
Facility Name
Univeristy of Milano Bicocca
City
Monza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Aliberti, MD
Email
stefano.aliberti@unimib.it
First Name & Middle Initial & Last Name & Degree
Stefano Aliberti, MD
First Name & Middle Initial & Last Name & Degree
Andrea Gori, MD
Facility Name
IRCCS Policlinico S. Matteo, University of Pavia
City
Pavia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Luisetti, MD
Email
m.luisetti@smatteo.pv.it
Facility Name
AO S. Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Zucchi, MD
Email
zucchi.luigi@asmn.re.it
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Voza, MD
Email
antonio.voza@humanitas.it
Facility Name
IRCCS Policlinico di San Donato Milanese, University of Milan
City
San Donato Milanese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Valenti, MD
Email
vincenzo.valenti@unimi.it
Facility Name
AO S. Maria della Misericordia,
City
Udine
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Rossi, MD
Email
rossi.paolo@aoud.sanita.fvg.it
First Name & Middle Initial & Last Name & Degree
Matteo Bassetti, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19926738
Citation
Aliberti S, Blasi F, Zanaboni AM, Peyrani P, Tarsia P, Gaito S, Ramirez JA. Duration of antibiotic therapy in hospitalised patients with community-acquired pneumonia. Eur Respir J. 2010 Jul;36(1):128-34. doi: 10.1183/09031936.00130909. Epub 2009 Nov 19.
Results Reference
background
PubMed Identifier
17278083
Citation
Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, Dowell SF, File TM Jr, Musher DM, Niederman MS, Torres A, Whitney CG; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007 Mar 1;44 Suppl 2(Suppl 2):S27-72. doi: 10.1086/511159. No abstract available.
Results Reference
background
PubMed Identifier
21951385
Citation
Woodhead M, Blasi F, Ewig S, Garau J, Huchon G, Ieven M, Ortqvist A, Schaberg T, Torres A, van der Heijden G, Read R, Verheij TJ; Joint Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases. Guidelines for the management of adult lower respiratory tract infections--full version. Clin Microbiol Infect. 2011 Nov;17 Suppl 6(Suppl 6):E1-59. doi: 10.1111/j.1469-0691.2011.03672.x.
Results Reference
background

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Duration of Antibiotic Therapy in Community - Acquired Pneumonia

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