None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Ceftaroline, at a dose of 600 mg, infused IV, 60 minutes, every 12 hours, for 5 to 7 days.
Group name:GROUP 2 Type of group
This group will be treated with Ceftriaxone, at a dose of 1 g, infused IV, 60 minutes, QD + Ceftriaxone Placebo, infused IV, 60 minutes, QD
This scheme will be administered for 5 to 7 days.
Sponsors
I3 LATIN AMERICA PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women 18 years of age or older. 2. Pneumonia acquired in the community that meets the following criteria: A) Pneumonia confirmed by radiography. AND B) Acute disease (≤ 7 days duration) with at least three clinical signs or symptoms consistent with a lower respiratory tract infection. 3. The subject must require initial admission or treatment in an emergency room or urgent care setting, according to the standard of care. 4. The infection of the subject will require, according to the standard of care, an initial treatment with intravenous antimicrobials. 5. Women of childbearing age and those with less than 2 years of postmenopause should agree and commit to using highly effective contraceptive methods while they are participating in this study. 6. Written informed consent, willingness and ability to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. PORT score less than or equal to 50. 2. CAP suitable for outpatient treatment with an oral antimicrobial agent. 3. Respiratory tract infections attributable to sources other than bacterial pathogens acquired in the community. 4. Non-infectious causes of pulmonary infiltrates. 5. Pleural empyema. 6. Microbiologically documented infection with a pathogen known to be resistant to ceftriaxone, or an epidemiological or clinical context that suggests a high probability of typical bacterial pathogen resistant to ceftriaxone. 7. Pre-treatment with an antimicrobial for the treatment of CAP within 96 hours leading to randomization. 8. Failure of ceftriaxone as therapy for this episode of CAP, or previous isolation of a resistant organism in vitro to ceftriaxone. 9. History of any type of hypersensitivity or allergic reaction to any B-lactam antimicrobial. 10. Previous or current history of epilepsy or seizure disorder. 11. Concomitant antimicrobial or systemic antifungal treatment requirement for any reason. 12. Neoplastic pulmonary disease, cystic fibrosis, progressively fatal disease, chronic neurological disorder that prevents the elimination of pulmonary secretions, or life expectancy less than or equal to 3 months. 13. Probenecid administration within 3 days prior to the start of treatment with the study drug or need for concomitant treatment with probenecid. 14. Infections or conditions that require concomitant systemic corticosteroids. 15. Severely impaired renal function. 16. Evidence of significant hepatic, hematological or immunological disease. 17. Evidence of immediately threatening disease for life. 18. Residence in a nursing home or in a geriatric institution or hospitalization within 14 days prior to the onset of symptoms. 19. Pregnant or breastfeeding women. 20. Participation in any study that involves the administration of an agent or device under investigation within 30 days prior to randomization in this study or previous participation in the current study 21. Previous participation in a study with ceftaroline 22. Can not or is not willing to follow the specific procedures and restrictions of the study 23. Any condition that, at the discretion of the principal investigator, would compromise the subject´s safety or the quality of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The Success Rate is determined by the Clinical Response and Successful Radiographic Response. The clinical response is evaluated medically, confirming the resolution all signs and symptoms of pneumonia or improvement to such an extent that no additional antimicrobial treatment is required. The radiographic success is evaluated by chest radiography or chest CT, where the lesions resolved, improved or are stable. Measure:Total success rate in the TOC visit. Timepoints:Days 10 - 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1, 2 and 4: Clinical evaluation that determines the resolution of all signs and symptoms of pneumonia or improvement to such an extent that additional antimicrobial treatment is no longer required. Criteria 3 and 4: Sputum, blood and / or pleural fluid cultures, in which the microbiological success is defined as: Eradication (Absence of the original basal pathogen) or Presumed eradication (There was no adequate source sample available to perform a culture and the subject was evaluated as clinical cure). Criterion 5: Medical evaluation of patients considered clinically cured, who at the LFU visit, show relapse (signs and symptoms of pneumonia that require additional antimicrobial treatment). Criterion 6: Sputum, blood and / or pleural fluid cultures during the LFU visit, in which Reinfection / Recurrence refers to an isolation of a basal pathogen (recurrence) or of a new pathogen (reinfection). Measure:Secondary Efficacy: 1) Clinical Cure Rate in the TOC visit. 2) Clinical Cure Rate in the EOT visit. 3) Microbiological Success Rate in the TOC Visit. 4) Rate of Clinical Healing and Microbiological Success by Pathogen in the TOC Visit. 5) Clinical Relapse Rate in the LFU Visit. 6) Microbiological Rate of Reinfection / Recurrence at the LFU Visit. Timepoints:Criteria 1, 3 and 4: Days 10 -20. Criterion 2: Day 7. Criteria 5 and 6: Days 25-37. ; Outcome name:Criteria 1 and 2: RX or chest CT, which resolved, improved or is stable compared to baseline. Criterion 3: Clinical evaluation. Criterion 4: Sputum, blood and / or pleural fluid cultures, in which Superinfection or Colonization is identified. Criterion 5: Positive blood cultures. Criterion 6: Sputum, blood and / or pleural fluid cultures, in which a 4-fold increase in the Minimum Inhibitory Concentration (MIC) is observed. Measure:Additional Efficacy Criteria: 1) Radiographic Success Rate in the TOC visit. 2) Radiographic Success Rate at the L | — |
Countries
Argentina, Austria, Bulgaria, Chile, Germany, Hungary, India, Latovia, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine, United States
Outcome results
None listed