- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01492387
Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)
Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Stefano Aliberti, MD
- Phone Number: 00393394171538
- Email: stefano.aliberti@unimib.it
Study Contact Backup
- Name: Francesco Blasi, MD
- Email: francesco.blasi@unimi.it
Study Locations
-
-
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Bergamo, Italy
- Not yet recruiting
- AO Ospedali Riuniti Bergamo
-
Contact:
- Giovanni Michetti, MD
- Email: gmichetti@ospedaliriuniti.bergamo.it
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Bologna, Italy
- Recruiting
- AO Policlinico S. Orsola Malpighi, University of Bologna
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Como, Italy
- Recruiting
- AO S. Anna
-
Contact:
- Anna Rosa Maspero, MD
- Email: anna.maspero@hsacomo.org
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Genoa, Italy
- Not yet recruiting
- University of Genoa
-
Contact:
- Claudio Viscoli, MD
- Email: claudio.viscoli@unige.it
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Mantova, Italy
- Not yet recruiting
- AO C. Poma
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Contact:
- Carlo Sturani, MD
- Email: carlo.sturani@aopoma.it
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Milan, Italy
- Recruiting
- AO San Carlo Borromeo
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Contact:
- Sandro Amaducci, MD
- Email: amaducci.sandro@sancarlo.mi.it
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Milan, Italy
- Recruiting
- IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
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Contact:
- Francesco Blasi, MD
- Email: francesco.blasi@unimi.it
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Sub-Investigator:
- Roberto Cosentini, MD
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Milan, Italy
- Recruiting
- Ospedale Luigi Sacco, University of Milan
-
Contact:
- Nicola Montano, MD
- Email: nicola.montano@unimi.it
-
Principal Investigator:
- Fabio Franzetti, MD
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Modena, Italy
- Not yet recruiting
- University of Modena e Reggio Emilia
-
Contact:
- Luca Richeldi, MD
- Email: luca.richeldi@unimore.it
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Monza, Italy
- Recruiting
- Univeristy of Milano Bicocca
-
Contact:
- Stefano Aliberti, MD
- Email: stefano.aliberti@unimib.it
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Principal Investigator:
- Stefano Aliberti, MD
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Sub-Investigator:
- Andrea Gori, MD
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Pavia, Italy
- Not yet recruiting
- IRCCS Policlinico S. Matteo, University of Pavia
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Contact:
- Maurizio Luisetti, MD
- Email: m.luisetti@smatteo.pv.it
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Reggio Emilia, Italy
- Recruiting
- AO S. Maria Nuova
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Contact:
- Luigi Zucchi, MD
- Email: zucchi.luigi@asmn.re.it
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Rozzano, Italy
- Not yet recruiting
- Istituto Clinico Humanitas
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Contact:
- Antonio Voza, MD
- Email: antonio.voza@humanitas.it
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San Donato Milanese, Italy
- Recruiting
- IRCCS Policlinico di San Donato Milanese, University of Milan
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Contact:
- Vincenzo Valenti, MD
- Email: vincenzo.valenti@unimi.it
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Udine, Italy
- Not yet recruiting
- AO S. Maria della Misericordia,
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Contact:
- Paolo Rossi, MD
- Email: rossi.paolo@aoud.sanita.fvg.it
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Principal Investigator:
- Matteo Bassetti, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
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.
Study Plan
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
Sponsor
Collaborators
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
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pleural Diseases
- Bronchial Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Pleurisy
- Pneumonia
- Pneumonia, Viral
- Pneumonia, Bacterial
- Pleuropneumonia
- Bronchopneumonia
- Anti-Infective Agents
- Anti-Bacterial Agents
Other Study ID Numbers
- DURATION
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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