None listed
Conditions
Interventions
Patients in this arm will receive RO4908463 750 mg reconstituted in 100 ml of 0.9% NaCl q/12 hours 1 hours IV for 60 minutes
Group name:Arm C Type of group
Patients in this arm will receive Ceftriaxone 1000 mg c / 24 h in 0.9% NaCl for 12 hours to simulate the infusion of RO4908463
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes> 18 years of age requiring hospitalization with pneumonia acquired in the community or who develop pneumonia within 48 hours after their hospitalization 2. Having a fever, defined as body temperature> 38.0 ° C (100.4 ° F) oral; or> 38.5 ° C (101.2 ° F) tympanic 3. That they present a new cough or increase of a productive preexisting cough, with purulent sputum for culture and susceptibility tests. 4. Having either pleuritic chest pain, dyspnea, or tachypnea 5. That they present auscultatory findings indicative of pneumonic consolidation or pneumopathic process compatible with the diagnosis of pneumonia 6. With confirmatory thoracic radiography of infiltrate or lobular consolidacton 7. Patients with samples of respiratory secretion and two cultures of blood. 8. With a negative determination of the Legionella antigen in urine (Binax® Method) 9. Have an APACHE II score between 9 and <24 10. If the patient has sexual intercourse and is a woman of childbearing age, or is a male has a female partner of childbearing age, the patient agrees to use during the period of study two contraceptive methods, of which at least one is a method of barrier. 11. With a high total leukocyte count in peripheral blood 12. That they have signed an informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with a Pneumonia Severity Index 500 ml 11. With primary lung cancer or some malignant metastatic tumor in the lungs 12. Show signs of meningitis 13. With known or suspected cystic fibrosis or with suspected active tuberculosis 14. With known or suspected concomitant bacterial infection requiring antibiotic treatment 15. That require chronic immunosuppressive therapy or that are expected to require immunosuppressive therapy> 1 month from baseline 16. Having neutropenia or platelet count <50,000 / mm ^ 17. Having any form of epilepsy or a history of seizures 18. Have been addicted to alcohol or drugs in the last six months 19. Having hypersensitivity to beta-lactam antibiotics 20. Have received more than one dose of a 3° Generation cephalosporin or any dose of a quinolone, macrolide or ketolide within 24 hours of randomization. 21. Have a history of stroke, transient ischemia, brain metastasis, expansive CNS lesion or systemic cancer in the last year and / or are receiving complementary chemotherapy 22. Being treated or likely to be treated with coumarin or probenecid during the study 23. Have a creatinine clearance, using the Cockroft-Gault equation, <70 ml / min 24. Having significant proteinuria 25. That show evidence of liver dysfunction 26. Having a history of hemolytic anemia 27. Having valvular or vascular prostheses 28. With known HIV infection or AIDS with a CD4 count <250 cells / mm and receiving antiretroviral treatment 29. That it is unlikely that they will comply with the administration regime, the scheduled evaluations or that they complete the study for any other reason 30. That have been previously randomized in this study or that are members of the auxiliary personnel involved in this study 31. That they are pregnant or breastfeeding 32. Having a concomitant illness that could make it impossible to evaluate the response or due to which they are unlikely to complete a treatment cycle and follow-up evaluations 33. That they have received a drug in the research phase within 30 days prior to entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Module: Clinical Evaluation of Acquired Pneumonia in the Community: Clinical cure is defined as compliance with the criteria of clinical improvement and presence of a complete or substantial improvement of the symptoms of pneumonia. Measure:Clinical cure rate. Timepoints:Clinical evaluation: 15-18 days after treatment. Module: Clinical Evaluation of Pneumonia Acquired in the Community : Every 12 ± 2 h during the administration of study IV medication (days 1 to 14) and 15-18 days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Culture and sensitivity test of blood and sputum samples Measure:In vitro susceptibility data on RO4908463 in pathogenic isolated organisms Timepoints:At the beginning of the treatment ; Outcome name:Concentration of RO4908463 in samples of plasma, urine, epithelial lining fluid and creatinine levels Measure:Pharmacokinetics of RO4908463 Timepoints:Days 1, 3 and 4 of the treatment ; Outcome name:Clinical evaluation of apirexia, quality and quantity of sputum, cough, dyspnea, pleuritic chest pain, chills, pulse oximetry and ventilation. Measure:Time until the resolution of the signs and symptoms of pneumonia. Timepoints:The evaluation of these signs and symptoms will be done during the clinical evaluation of community-acquired pneumonia: Every 12 ± 2 h during the administration of study IV medication (days 1 to 14) and days 15-18 after treatment . ; Outcome name:Blood cultures (with susceptibility tests) if they were positive at baseline. Blood cultures should be obtained from two different places with an interval of at least five minutes. Measure:Bacteriological response: Rates of Eradication, Presumed eradication, Persistence, Resistance acquired, Presumed resistance, Superinfection, Recurrence. Defined according to the presence or absence of the pathogen in post-treatment blood cultures. Timepoints:At the end of the treatment, in the early follow-up visit (1 to 4 days after the suspension of treatment) and 15 to 18 days after the treatment. ; Outcome name:Clinical evaluation: Application of the evaluation module called Clinical Evaluation of Acquired Pneumonia in the Community. Which categorizes the results of patients in 4 categories: Clinical improvement, Clinical cure, Clinical failure and Indefinite. Measure:Number and percentage of patients with each of the results in the Evaluation of the Treatment of Pneumonia by the Researcher. Timepoints:Clinical evaluation: 15-18 days | — |
Countries
Argentina, Bulgaria, Chile, Croatia, Hungary, Lithuania, Peru, Romania, Slovakia, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed