Community-acquired pneumonia
Conditions
Interventions
Product Code: RO 490 8463
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: RO 490 8463
Other descriptive name: CS 023
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
F.Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will qualify to participate in this study if they meet all of the following: 1. Are male or female patients greater than or equal to 18 years of age that require hospitalization with community-acquired pneumonia or develops pneumonia within 48 hours of hospitalization for another condition. 2. Have fever defined as body temperature > 38.0°C (100.4°F) taken orally; or > 38.5°C (101.2°F) tympanically; OR have hypothermia, defined as rectal or core body temperature =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet any of the following: 1. Have a Pneumonia Severity Index = 90. 2. Have presented with sustained shock, defined as systolic blood pressure 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure. 3. In the opinion of the investigator, history, physical examination and chest X-ray findings are most consistent with an atypical pneumonia. 4. Require endotracheal intubation and ventilation, or in the opinion of the investigator, are expected to require it. 5. Are likely to be discharged in less than 3 days. 6. Developed pneumonia after more than 48 hours of admission to hospital. 7. Have been a resident in a nursing home or extended care facility within 60 days prior to randomization. 8. Require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion. 9. Have a known bronchial obstruction or a history of post-obstructive pneumonia. 10. Have known or suspected lung abscess, empyema, or evidence of a pleural effusion estimated to be > 500 mL. 11. Have primary lung cancer or another malignancy metastatic to the lungs. 12. Have signs of meningitis such as nuchal rigidity, papilledema or other findings of meningitis. (Note: The penetration of RO4908463 into the cerebral spinal fluid (CSF) has not yet been determined.) 13. Have known or suspected cystic fibrosis or suspected active tuberculosis. 14. Have known or suspected concomitant bacterial infection requiring antibiotic treatment. 15. Require chronic immunosuppressive therapy or have an anticipated need for immunosuppressive therapy for > 1 month from baseline (including > 10 mg/day of systemic prednisone or equivalent). 16. Have neutropenia (ANC 1.0% or > 10g/L on urinalysis). 25. Have evidence of a liver dysfunction manifested by: ALT or AST = 4X ULN or total bilirubin > 1.5X ULN. 26. Have a history of hemolytic anemia. 27. Have artificial heart valves or vascular prostheses. 28. Have known HIV infection or AIDS with a CD4 count < 250 cells/mm3 and are taking antiretroviral therapy or in the opinion of the investigator should begin antiretroviral treatments or have undiagnosed HIV infection but have clinical findings highly suggestive of HIV/AIDS. 29. Are unlikely to comply with the dosing regimen, scheduled assessments, or complete the study for any other reason. 30. Have previously been randomized into this study or are ancillary personnel involved with this study. 31. Are pregnant or nursing. 32. Have any concomitant condition which could preclude evaluation of response or ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety, tolerance and efficacy of parenteral RO4908463 to ceftriaxone in patients with community-acquired pneumonia requiring hospitalization without evidence of Legionella.;Secondary Objective: To obtain in vitro susceptibility data on RO4908463 on the pathogenic organisms isolated from patients participating in the study. To evaluate the pharmacokinetics of RO4908463 in the patient population including the influence of covariates. To explore the relationship of drug exposure (time above minimum inhibitory concentration (MIC)) to clinical cure rates in the bacteriologic evaluable population.;Primary end point(s): The primary efficacy variable is the clinical cure rate at the end of study evaluation visit. | — |
Countries
Hungary, Latvia, Lithuania
Outcome results
None listed