None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Ceftobiprole 500 mg in 250 ml IV for 120 minutes TID for 7 to 28 days according to clinical evaluation. Linezolid placebo in 300 ml IV for 60 minutes IDB for 7 to 28 days according to clinical evaluation.
Group name:GROUP 2 Type of group
This group will be treated with Ceftazidime 2 g in 250 ml IV for 120 minutes TID for 7 to 28 days according to clinical evaluation. Linezolid 600 mg in 300 ml IV for 60 minutes IDB for 7 to 28 days according to clinical evaluation.
Sponsors
JHONSON & JHONSON PHARMACEUTICALS,
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Informed consent granted in writing. The consent of patients in a state of unconsciousness / incapacity may be granted by their direct relatives, guardians or legal representatives. 2) Subjects men and women ≥ 18 years of age. 3) Before beginning and throughout the entire study, women should be postmenopausal, surgically sterile or be practicing some effective method of birth control and the pregnancy test should be negative. 4) Subjects suffering from NP or VAP. 5) Microbiological samples suitable for culture and microscopy. 6) APACHE II score ≥ 8 and ≤ 25.
Exclusion criteria
Exclusion criteria: 1. Subjects women who are pregnant or breastfeeding. 2. Known or suspected hypersensitivity to any medication of the study. 3. Any known or suspected concurrent treatment or treatment contraindicated by the prescription information of linezolid or ceftazidime. 4. Severe deterioration of renal function. 5. Known or suspected hepatic dysfunction. 6. Baseline QTcB (Bazett correction)> 450 msec. 7. Previous enrollment in this study. 8. Treatment with any investigational medication within 30 days prior to enrollment. 9. Any other known or suspected disease of the subject, which could jeopardize compliance with the requirements of the protocol. 10. Known HlV-positive with count of ≤ 200 cells / mm3. 11. Presence of myelosuppression or neutropenia, severe anemia. 12. Children or other family members of the researcher or employees of the study center. 13. Sustained shock. 14. Subjects with: a) Confirmed bronchial obstruction or a history of postobstructive pneumonia, primary lung cancer or other metastatic malignancy of the lungs. b) Cystic fibrosis. c) Lung abscess. c) Pleural effusion as a source of primary infection. e) Active tuberculosis. f) Subjects that require antibiotic coverage due to aspiration pneumonia, atypical pneumonia or Pneumocystis jiroveci pneumonia. 15) Systemic antimicrobial therapy for more than 24 hours within 7 days prior to enrollment. 16) Evidence in available control cultures of coinfection with pathogens such as: Producers of ESBL, Proteus vuigaris and non-fermentors resistant to ceftazidime or ceftobiprole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Measure:Primary cure rate: number of subjects cured clinically in relation to the total number of subjects in the population in the visit of the healing test (OCD). Timepoints:Before treatment and on days 4, 8, 14, at the end of treatment and during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Culture of respiratory secretion and Gram stain. Blood culture. Clinical evaluation. Measure:Microbiological eradication rate. Clinical cure rate and microbiological relapse in the follow-up visit. Rates of specific mortality due to pneumonia. Timepoints:Before treatment and on days 4, 8, 14, at the end of treatment and during follow-up. ; Outcome name:Culture of respiratory secretion and Gram stain. Blood culture Clinical evaluation Measure:Mortality rate from any cause. Time to clinical cure. Time until microbiological eradication. Treatment duration. Clinical cure rate and microbiological eradication with VAP subjects. Data on the use of medical resources. Timepoints:Before treatment and on days 4, 8, 14, at the end of treatment and during follow-up. ; Outcome name:Monitoring of adverse events. Chest x-ray 12-lead ECG. Clearance of creatinine. Laboratory tests: hematology panel, serum biochemistry panel, urine test. Measure:Safety and tolerability of the treatment. Timepoints:Monitoring of adverse events: Before treatment and on days 4, 8, 14, at the end of treatment and during follow-up. Laboratory tests: Before treatment and at the end of this. | — |
Countries
Argentina, Brazil, Canada, Chile, China, Costa Rica, Czech Republic, Italy, Mexico, Peru, United States
Outcome results
None listed