NCT01492387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
892

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 3, 2014

Status Verified

December 1, 2013

Enrollment Period

2.9 years

First QC Date

December 5, 2011

Last Update Submit

December 31, 2013

Conditions

PneumoniaBronchopneumoniaPleuropneumoniaPneumonia, BacterialPneumonia, Viral

Keywords

community-acquired pneumoniahealthcare-associated pneumoniaantibiotic therapyDuration of therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Secondary Outcomes (6)

  • Composite outcome of other adverse events

    30 days

  • Antibiotic exposure

    90 days

  • Adverse effects

    90 days

  • Composite outcome of other adverse events at 90 days

    90 days

  • Length of hospitalization

    30 days

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Discontinuation of antibiotic therapy

Interventions

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.

Individualized arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

AO Ospedali Riuniti Bergamo

Bergamo, Italy

NOT YET RECRUITING

AO Policlinico S. Orsola Malpighi, University of Bologna

Bologna, Italy

RECRUITING

AO S. Anna

Como, Italy

RECRUITING

University of Genoa

Genoa, Italy

NOT YET RECRUITING

AO C. Poma

Mantova, Italy

NOT YET RECRUITING

AO San Carlo Borromeo

Milan, Italy

RECRUITING

IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Ospedale Luigi Sacco, University of Milan

Milan, Italy

RECRUITING

University of Modena e Reggio Emilia

Modena, Italy

NOT YET RECRUITING

Univeristy of Milano Bicocca

Monza, Italy

RECRUITING

IRCCS Policlinico S. Matteo, University of Pavia

Pavia, Italy

NOT YET RECRUITING

AO S. Maria Nuova

Reggio Emilia, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Italy

NOT YET RECRUITING

IRCCS Policlinico di San Donato Milanese, University of Milan

San Donato Milanese, Italy

RECRUITING

AO S. Maria della Misericordia,

Udine, Italy

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 19926738BACKGROUND

  • 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.

    PMID: 17278083BACKGROUND

  • 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.

    PMID: 21951385BACKGROUND

MeSH Terms

Conditions

PneumoniaBronchopneumoniaPleuropneumoniaPneumonia, BacterialPneumonia, ViralCommunity-Acquired PneumoniaHealthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBronchial DiseasesPleurisyPleural DiseasesBacterial InfectionsBacterial Infections and MycosesVirus DiseasesCommunity-Acquired InfectionsCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefano Aliberti, MD

    University of Milano Bicocca, Milan, Italy

    PRINCIPAL INVESTIGATOR

  • Julio A Ramirez, MD

    University of Louisville, KY, USA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Aliberti, MD

CONTACT

00393394171538stefano.aliberti@unimib.it

Francesco Blasi, MD

CONTACT

francesco.blasi@unimi.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 15, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

January 3, 2014

Record last verified: 2013-12

Locations

IT(15)