Duration of Antibiotic Therapy in Community - Acquired Pneumonia (DURATION)
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| ClinicalTrials.gov Identifier: NCT01492387 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia Bronchopneumonia Pleuropneumonia Pneumonia, Bacterial Pneumonia, Viral | Other: Discontinuation of antibiotic therapy | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 892 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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. |
| Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | December 2014 |
| Estimated Study Completion Date : | March 2015 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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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. |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492387
| Contact: Stefano Aliberti, MD | 00393394171538 | stefano.aliberti@unimib.it | |
| Contact: Francesco Blasi, MD | francesco.blasi@unimi.it |
| 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 | |
| AO San Carlo Borromeo | Recruiting |
| Milan, Italy | |
| Contact: Sandro Amaducci, MD amaducci.sandro@sancarlo.mi.it | |
| IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico | Recruiting |
| Milan, Italy | |
| Contact: Francesco Blasi, MD francesco.blasi@unimi.it | |
| Sub-Investigator: Roberto Cosentini, MD | |
| Ospedale Luigi Sacco, University of Milan | Recruiting |
| Milan, Italy | |
| Contact: Nicola Montano, MD nicola.montano@unimi.it | |
| Principal Investigator: Fabio Franzetti, MD | |
| 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 | |
| Principal Investigator: | Stefano Aliberti, MD | University of Milano Bicocca, Milan, Italy | |
| Principal Investigator: | Julio A Ramirez, MD | University of Louisville, KY, USA |
Additional Information:
Publications:
| Responsible Party: | Francesco Blasi, Professor, University of Milan |
| ClinicalTrials.gov Identifier: | NCT01492387 History of Changes |
| Other Study ID Numbers: |
DURATION |
| First Posted: | December 15, 2011 Key Record Dates |
| Last Update Posted: | January 3, 2014 |
| Last Verified: | December 2013 |
Keywords provided by Francesco Blasi, University of Milan:
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community-acquired pneumonia healthcare-associated pneumonia antibiotic therapy Duration of therapy |
Additional relevant MeSH terms:
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Pneumonia Pneumonia, Bacterial Pneumonia, Viral Pleuropneumonia Bronchopneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Bacterial Infections |
Virus Diseases Pleurisy Pleural Diseases Bronchial Diseases Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |