Duration of Antibiotic Therapy in Community - Acquired Pneumonia

NCT ID: NCT01492387

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 892 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Pneumonia; Bronchopneumonia; Pleuropneumonia; Pneumonia, Bacterial; Pneumonia, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Local standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Discontinuation of antibiotic therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Francesco Blasi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Aliberti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milano Bicocca, Milan, Italy

Julio A Ramirez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, KY, USA

Locations

AO Ospedali Riuniti Bergamo

Bergamo, , Italy

Site Status: NOT_YET_RECRUITING

AO Policlinico S. Orsola Malpighi, University of Bologna

Bologna, , Italy

Site Status: RECRUITING

AO S. Anna

Como, , Italy

Site Status: RECRUITING

University of Genoa

Genoa, , Italy

Site Status: NOT_YET_RECRUITING

AO C. Poma

Mantova, , Italy

Site Status: NOT_YET_RECRUITING

AO San Carlo Borromeo

Milan, , Italy

Site Status: RECRUITING

IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status: RECRUITING

Ospedale Luigi Sacco, University of Milan

Milan, , Italy

Site Status: RECRUITING

University of Modena e Reggio Emilia

Modena, , Italy

Site Status: NOT_YET_RECRUITING

Univeristy of Milano Bicocca

Monza, , Italy

Site Status: RECRUITING

IRCCS Policlinico S. Matteo, University of Pavia

Pavia, , Italy

Site Status: NOT_YET_RECRUITING

AO S. Maria Nuova

Reggio Emilia, , Italy

Site Status: RECRUITING

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status: NOT_YET_RECRUITING

IRCCS Policlinico di San Donato Milanese, University of Milan

San Donato Milanese, , Italy

Site Status: RECRUITING

AO S. Maria della Misericordia,

Udine, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Stefano Aliberti, MD

Role: CONTACT

stefano.aliberti@unimib.it

00393394171538

Francesco Blasi, MD

Role: CONTACT

francesco.blasi@unimi.it

Facility Contacts

Giovanni Michetti, MD

Role: primary

gmichetti@ospedaliriuniti.bergamo.it

Pierluigi Viale, MD

Role: primary

pierluigi.viale@unibo.it

Anna Rosa Maspero, MD

Role: primary

anna.maspero@hsacomo.org

Claudio Viscoli, MD

Role: primary

claudio.viscoli@unige.it

Carlo Sturani, MD

Role: primary

carlo.sturani@aopoma.it

Sandro Amaducci, MD

Role: primary

amaducci.sandro@sancarlo.mi.it

Francesco Blasi, MD

Role: primary

francesco.blasi@unimi.it

Nicola Montano, MD

Role: primary

nicola.montano@unimi.it

Luca Richeldi, MD

Role: primary

luca.richeldi@unimore.it

Stefano Aliberti, MD

Role: primary

stefano.aliberti@unimib.it

Maurizio Luisetti, MD

Role: primary

m.luisetti@smatteo.pv.it

Luigi Zucchi, MD

Role: primary

zucchi.luigi@asmn.re.it

Antonio Voza, MD

Role: primary

antonio.voza@humanitas.it

Vincenzo Valenti, MD

Role: primary

vincenzo.valenti@unimi.it

Paolo Rossi, MD

Role: primary

rossi.paolo@aoud.sanita.fvg.it

References

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.

Reference Type: BACKGROUND

PMID: 19926738 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17278083 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21951385 (View on PubMed)

Other Identifiers

DURATION

Identifier Type: -

Identifier Source: org_study_id