Individualizing duration of antibiotic therapy in hospitalized patients with pneumonia

Individualizing duration of antibiotic therapy in hospitalized patients with community-acquired pneumonia: a non-inferiority, randomized, controlled trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003176-36-IT

Enrollment

892

Registered

2011-12-28

Start date

2011-12-20

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with diagnosis of pneumonia MedDRA version: 14.1 Level: LLT Classification code 10035739 Term: Pneumonia, organism unspecified System Organ Class: 10021881 - Infections and infestations

Interventions

Pharmaceutical Form: INN or Proposed INN: LEVOFLOXACIN CAS Number: 100986854 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical Form: INN or Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of pneumonia 2) Having received an 'adequate empirical antibiotic therapy for pneumonia within 24 hours of admission to hospital. 3) have achieved clinical stability within 5 days of hospitalization, in the absence of changes to the initial empirical antibiotic therapy. 4) Have signed the informed consent 5)> 18 years Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 800

Exclusion criteria

Exclusion criteria: 1) patients with immune deficiency, defined as: chemotherapy in the previous 12 months, radiotherapy in the previous 12 months, transplantation, immunosuppressive treatment, haematological malignancy, AIDS or HIV infection with CD4 counts <200, asplenia. 2) Patients with other concomitant infection at the time of hospitalization that requires antibiotic treatment. 3) Patients with documented bacteremia with S. aureus. 4) Patients with pneumonia caused by fungi, mycobacteria, or Pneumocystis jiroveci

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of non-inferiority of duration of individualized antibiotic therapy at clinical stability versus standard duration of therapy.;Timepoint(s) of evaluation of this end point: 30 days;Secondary Objective: 1.composite outcome due to pneumonia, estimated to be 30 days from diagnosis of pneumonia. 2. Global exposure to antibiotics, administered intravenously or oraly for any reason. 3. Negative effects produced by the antibiotic treatment 4. Composite outcome at 90 days from diagnosis of pneumonia, including at least one of: 1) a new round of antibiotics administered for any reason, after stopping the antibiotics given for pneumonia, 2) re-hospitalization for any reason, and 3) death from any cause. 5. Duration of hospitalization. 6. Differences in costs of care between the two study groups.;Primary end point(s): Primary non-inferiority end-point: To determine a composite outcome occurring within 30 days following the diagnosis of pneumonia, including any among the following: 1) disease-specific complications, such as lung abscess, empyema, meningitis, endocarditis, arthritis or pericarditis; 2) clinical failure occurring during hospitalization (either hemodynamic or respiratory failure, see definition); 3) a new course of antibiotics (at least one dose) either endovenous or oral for any reason after discontinuation of antibiotic therapy given for the pneumonia; 4) re-hospitalization for any reason; 5) death from any reason. Outcome will be assessed during the hospital stay by a blinded study investigator if the patient will be still hospitalized at day 30 after the diagnosis of pneumonia. Outcome will be assessed by a blinded study investigator during a clinic visit at day 30 after the diagnosis of pneumonia with a chest radiograph (CXR) and blood exams for inflammatory markers if patients will be discharged before day 30.	—

Measure

Time frame

Main Objective: Assessment of non-inferiority of duration of individualized antibiotic therapy at clinical stability versus standard duration of therapy.;Timepoint(s) of evaluation of this end point: 30 days;Secondary Objective: 1.composite outcome due to pneumonia, estimated to be 30 days from diagnosis of pneumonia. 2. Global exposure to antibiotics, administered intravenously or oraly for any reason. 3. Negative effects produced by the antibiotic treatment 4. Composite outcome at 90 days from diagnosis of pneumonia, including at least one of: 1) a new round of antibiotics administered for any reason, after stopping the antibiotics given for pneumonia, 2) re-hospitalization for any reason, and 3) death from any cause. 5. Duration of hospitalization. 6. Differences in costs of care between the two study groups.;Primary end point(s): Primary non-inferiority end-point: To determine a composite outcome occurring within 30 days following the diagnosis of pneumonia, including any among the following: 1) disease-specific complications, such as lung abscess, empyema, meningitis, endocarditis, arthritis or pericarditis; 2) clinical failure occurring during hospitalization (either hemodynamic or respiratory failure, see definition); 3) a new course of antibiotics (at least one dose) either endovenous or oral for any reason after discontinuation of antibiotic therapy given for the pneumonia; 4) re-hospitalization for any reason; 5) death from any reason. Outcome will be assessed during the hospital stay by a blinded study investigator if the patient will be still hospitalized at day 30 after the diagnosis of pneumonia. Outcome will be assessed by a blinded study investigator during a clinic visit at day 30 after the diagnosis of pneumonia with a chest radiograph (CXR) and blood exams for inflammatory markers if patients will be discharged before day 30.

—

Secondary

Measure	Time frame
Secondary end point(s): 1.composite outcome due to pneumonia, estimated to be 30 days from diagnosis of pneumonia. 2. Global exposure to antibiotics, administered intravenously or oraly for any reason. 3. Negative effects produced by the antibiotic treatment 4. Composite outcome at 90 days from diagnosis of pneumonia, including at least one of: 1) a new round of antibiotics administered for any reason, after stopping the antibiotics given for pneumonia, 2) re-hospitalization for any reason, and 3) death from any cause. 5. Duration of hospitalization. 6. Differences in costs of care between the two study groups.;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Secondary end point(s): 1.composite outcome due to pneumonia, estimated to be 30 days from diagnosis of pneumonia. 2. Global exposure to antibiotics, administered intravenously or oraly for any reason. 3. Negative effects produced by the antibiotic treatment 4. Composite outcome at 90 days from diagnosis of pneumonia, including at least one of: 1) a new round of antibiotics administered for any reason, after stopping the antibiotics given for pneumonia, 2) re-hospitalization for any reason, and 3) death from any cause. 5. Duration of hospitalization. 6. Differences in costs of care between the two study groups.;Timepoint(s) of evaluation of this end point: 90 days

—

Countries

Italy

Contacts

Public ContactBroncopneumologia

Fondazione IRCCS ''Ca' Granda'' Ospedale Maggiore Policlinico

francesco.blasi@unimi.it02/50320627

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026