PneumoniaPhase 4DURATIONNCT01492387
Duration of Antibiotic Therapy in Community - Acquired Pneumonia
A Phase 4 study testing Discontinuation of antibiotic therapy in people with Pneumonia and Bronchopneumonia, run by University of Milan at 15 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bronchopneumonia, Pleuropneumonia
- What is being tested?
- Discontinuation of antibiotic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 892 participants
- Where
- 15 sitesItaly
- Study dates
- Jan 2012to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
Francesco Blasi, MD contact
15 sites in 1 country
Italy15 sites, 15 recruiting
- Not yet recruiting
AO Ospedali Riuniti Bergamo
Bergamo
Giovanni Michetti, MD, gmichetti@ospedaliriuniti.bergamo.it
- Recruiting
AO Policlinico S. Orsola Malpighi, University of Bologna
Bologna
Pierluigi Viale, MD, pierluigi.viale@unibo.it
Stefano Nava, MD
- Recruiting
AO S. Anna
Como
Anna Rosa Maspero, MD, anna.maspero@hsacomo.org
- Not yet recruiting
University of Genoa
Genoa
Claudio Viscoli, MD, claudio.viscoli@unige.it
- Not yet recruiting
AO C. Poma
Mantua
Carlo Sturani, MD, carlo.sturani@aopoma.it
- Recruiting
AO San Carlo Borromeo
Milan
Sandro Amaducci, MD, amaducci.sandro@sancarlo.mi.it
- Recruiting
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
Milan
Francesco Blasi, MD, francesco.blasi@unimi.it
Roberto Cosentini, MD
- Recruiting
Ospedale Luigi Sacco, University of Milan
Milan
Nicola Montano, MD, nicola.montano@unimi.it
Fabio Franzetti, MD
- Not yet recruiting
University of Modena e Reggio Emilia
Modena
Luca Richeldi, MD, luca.richeldi@unimore.it
- Recruiting
Univeristy of Milano Bicocca
Monza
Stefano Aliberti, MD, stefano.aliberti@unimib.it
Stefano Aliberti, MD
- Not yet recruiting
IRCCS Policlinico S. Matteo, University of Pavia
Pavia
Maurizio Luisetti, MD, m.luisetti@smatteo.pv.it
- Recruiting
AO S. Maria Nuova
Reggio Emilia
Luigi Zucchi, MD, zucchi.luigi@asmn.re.it
- Not yet recruiting
Istituto Clinico Humanitas
Rozzano
Antonio Voza, MD, antonio.voza@humanitas.it
- Recruiting
IRCCS Policlinico di San Donato Milanese, University of Milan
San Donato Milanese
Vincenzo Valenti, MD, vincenzo.valenti@unimi.it
- Not yet recruiting
AO S. Maria della Misericordia,
Udine
Paolo Rossi, MD, rossi.paolo@aoud.sanita.fvg.it
Matteo Bassetti, MD
About this study
Official title: 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.
- Being tested
- Discontinuation of antibiotic therapy
- Keywords
- community-acquired pneumonia, healthcare-associated pneumonia, antibiotic therapy, Duration of therapy
- Medical subject headings
- Pneumonia, Bronchopneumonia, Pleuropneumonia, Pneumonia, Bacterial, Pneumonia, Viral, Community-Acquired Pneumonia, Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of antibiotic therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Local standard of care | No intervention | Patients randomized to this arm will be treated for the duration of therapy dictated by the primary care physician. |
| Individualized arm | Experimental | 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. Receives: Other: Discontinuation of antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
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.
Measured: 30 days
Antibiotic exposure
Days of antibiotic exposure, including intravenous and oral antibiotic therapy given for any reason.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 30 days
Costs
Costs of care differences between the two study groups based on the total length of hospital stay.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 892 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Principal investigator, Francesco Blasi, University of Milan
- Investigators
- Stefano Aliberti, MD, Principal investigator, University of Milano Bicocca, Milan, ItalyJulio A Ramirez, MD, Principal investigator, University of Louisville, KY, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492387
- Sponsor's protocol ID
- DURATION
- Acronym
- DURATION
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2011
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19926738Mandell 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.
PubMed 17278083Woodhead 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.
PubMed 21951385
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Duration of Antibiotic Therapy in Hospitalized Patients With Community - Acquired Pneumonia: a Non-inferiority, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01492387
- Acronym / sponsor ID
- DURATION / DURATION
- Keywords
- community-acquired pneumonia, healthcare-associated pneumonia, antibiotic therapy, Duration of therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 892 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local standard of care | No intervention | –Patients randomized to this arm will be treated for the duration of therapy dictated by the primary care physician. |
| Individualized arm | Experimental | Other: Discontinuation of antibiotic therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of antibiotic therapyPatients 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. | Other | Individualized arm |
Primary outcome
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.
6 secondary outcomes
Composite outcome of other adverse events
Time frame: 30 days
Antibiotic exposure
Time frame: 90 days
Adverse effects
Time frame: 90 days
Composite outcome of other adverse events at 90 days
Time frame: 90 days
Length of hospitalization
Time frame: 30 days
Costs
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
- Background: PubMed 19926738Aliberti 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.
- Background: PubMed 17278083Mandell 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.
- Background: PubMed 21951385Woodhead 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Blasi, MD contact
Stefano Aliberti, MD principal investigator
University of Milano Bicocca, Milan, Italy
Julio A Ramirez, MD principal investigator
University of Louisville, KY, USA
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinuation of antibiotic therapy in people with Pneumonia and Bronchopneumonia, run by University of Milan at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Aliberti, MD (00393394171538, stefano.aliberti@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome including adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492387, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.