None listed
Conditions
Interventions
GROUP A Type of group
This group will be treated with RO4908463 750 mg IV every 8 hours for a maximum of 14 days.
Group name:GROUP C Type of group
This group will be treated for a maximum of 14 days according to the criteria of the researcher choosing a medicine from each of the following 2 groups:
1) Penicillins resistant to penicillinase or Vancomycin: Nafcillin 2g IV every 4 hours OR Flucloxacillin 2g IV every 6-8 hours
OR Vancomycin 15 mg / kg IV every 12 hours.
2) Aztreonam 2 g IV every 6-8 hours OR Ciprofloxacin 400 mg IV every 8-12 hours.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The informed consent has been signed by the patient or has been signed by a legal representative recognized by the local authority. 2. Male or female patients> 18 years of age with skin infection or cutaneous structures requiring hospitalization. 3. If the patient is sexually active and is a woman of childbearing age, or is a man who has a female partner of childbearing age, the patient agrees to use two contraceptive methods during the study period, of which at least one is a barrier method 4. If the infection is located in an area adjacent to the bone, or if septic thrombophlebitis is suspected, an appropriate imaging study of the area should indicate the absence of evidence of osteomyelitis / thrombophlebitis within 24 hours after randomization. . 5. A suitable sample must be obtained for the cultivation and antibiogram. 6. Patients should have a clinical diagnosis of a skin infection and skin structures caused by a bacterium with known or suspected susceptibility to the study treatments. 7. The material of the place where the infection is located is clinically purulent or seropurulent. 8. The patient has received 37.5 ° C or a tympanic temperature> 37.9 ° C or a rectal temperature> 38.3 ° C during the previous 24 hours. 10. Presents at least two of the items listed below: a) white blood cell count> 10,000 mm or> 10% band neutrophil; b) local erythema; c) local swelling; d) pain on palpation; e) fluctuation; f) regional lymphangitis.
Exclusion criteria
Exclusion criteria: 1. The patient has presented sustained shock. 2. The patient is likely to be discharged in less than 3 days. 3. Requires hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion. 4. Presents osteomyelitis known or suspected in the area adjacent to the site affected by the infection of skin / skin structures. 5. Has septic thrombophlebitis known or suspected. 6. Has a known or suspected fungal, mycobacterial, viral or parasitic infection. 7. It has a burn of total thickness infected of any dimension or a burn that covers> 30% of the body surface. 8. The patient is using or is likely to use topical antibiotics. 9. The patient has received a drug in the research phase within the month prior to entering the study. 10. Have a known or suspected concomitant bacterial infection that requires treatment with antibiotics. 11. You have a skin infection or a chronic non-healing ulcer lasting> 2 weeks. 12. Patient in whom surgery constitutes the primary treatment. 13. Requires chronic immunosuppressive therapy or is expected to require immunosuppressive therapy> 1 month after the baseline visit. 14. Presents any form of epilepsy or a history of seizures. 15. Presents hypersensitivity to B-lactam antibiotics. 16. Has a history of a significant reaction to vancomycin. 17. Has a history of significant hypersensitivity reactions to antibiotic treatment against initial Gram-negative pathogens. 18. Has a history of stroke, transient ischemia, brain metastasis, expansive CNS lesion or systemic cancer in the last year and / or is receiving complementary chemotherapy. 19. Clearance of creatinine <80 ml / min. 20. Significant proteinuria. 21. Evidence of hepatic dysfunction. 22. Neutropenia or platelet count <50,000 / mm3. 23. History of hemolytic anemia. 24. It is unlikely that it complies with the administration regime, the scheduled assessments or to complete the study for any other reason. 25. Patient has artificial heart valves, artificial joints or vascular prostheses. 26. Patients who are being treated or who are likely to be treated with coumarin or probenecid during the study. 27. You have known HIV infection or AIDS with a CD4 count <250 cells / mm3 or that you are receiving antiretroviral treatment or that you should start antiretroviral treatments. 28. You are pregnant or breastfeeding. 29. Has a concomitant illness that could make it impossible to evaluate the response or due to which it is unlikely that they can complete a treatment cycle and follow-up evaluations. 30. Has been previously randomized to this study or is a member of the auxiliary personnel involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Where clinical cure is defined as compliance with clinical improvement criteria and there is a complete or substantial improvement of the symptoms of skin infection and skin structures. Measure:Clinical cure rate in the end of study evaluation visit (EOSE). Timepoints:7 to 10 days after the last day the patient received the study antibiotics, or more take the 39th day of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Categorization of the response in the evaluation in any of the following 4 categories: 1. Clinical improvement. 2. Clinical cure. 3. Clinical failure. 4. Indefinite. Measure:The number and percentage of patients with each response in the central evaluation of the treatment of skin infection and skin structures. Timepoints:Day 1 to 14 of the treatment, at the end of the treatment, Early Follow-up visit between 1 and 4 days and at the EOSE visit 7 to 10 days after treatment. ; Outcome name:Adverse events, vital signs, physical examinations, electrocardiograms and clinical laboratory analysis: hematology, including Coombs test (direct and indirect) and reticulocytes, blood chemistry, urine and urine hemosiderin analysis, protein / urine creatinine ratio, calculated creatinine clearance and B-NAG index (U / g Cr). Measure:Safety of the treatment. Timepoints:Evaluation of adverse events: Every day of treatment (from 1 to 14). Urinalysis, urinary hemosiderin, protein / Cr ratio in urine and Index Q-NAQ (U / e Cr), Hematology, blood chemistry: Days 1, 2, 3, 5, 7, 9, 11, 13. ECG: Days 1, 3, 4, 7, 10. ; Outcome name:Primary pharmacokinetic parameters: plasma drug clearance, volume of distribution. Secondary pharmacokinetic parameters: time on MIC, AUC, Cmax and Cmin. Measure:Pharmacological analyzes. Timepoints:Blood samples: Days 1, 3 and 4. Urinary samples: Days 1 and 2. ; Outcome name:Cultivation and antibiogram: A tissue biopsy, deep culture, puncture, incision or curetage should be obtained to perform culture and antibiogram before superficial swab of the site of infection. Measure:Bacteriological eradication rate: Number and percentage of patients with each bacteriological response (eradication, presumed eradication, resistance, acquired resistance, presumed persistence, superinfection, recurrence, new infection and colonization. Timepoints:At the end of the treatment | — |
Countries
Argentina, Bulgaria, Estonia, Germany, Greece, Hungary, Latovia, Lithuania, Peru, Romania, South Africa, United States
Outcome results
None listed