None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Telvancin 10 mg / kg IV every 24 hours for 7 to 14 days according to clinical evolution.
Group name:GROUP 2 Type of group
This group will be treated with Vancomycin 1g every 24 hours IV for 7 to 14 days according to clinical criteria.
Sponsors
THERAVANCE INC (OMNICARE CLINICAL RESEARCH),
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women> 18 years of age. 2. Patients should be diagnosed with a complicated skin and soft tissue infection by MRSA. 3. It is expected that patients require at least 7 days of treatment with intravenous antibiotics. 4. The following symptoms / signs must be present: Erythema, fluctuation, heat and / or localized increase in temperature, pain and / or sensitivity to palpation, swelling and / or induration, fever, white blood cell count> 10,000 / mm3,> 15 % of immature neutrophils. 5. Accessible site for cultivation. 6. Obtaining informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: 1. a) Individuals who received potentially effective systemic antibiotic therapy for more than 24 hours before randomization and / or b) Individuals requiring a systemic antibacterial regimen different from the study treatment. 2. Requirement for concomitant administration of agents containing a cyclodextrin solubilizer such as intravenous Sporanox® (itraconazole) or Vfend® (voriconazole). 3. Patients with QTc prior to treatment> 500 msec, congenital prolonged QT syndrome, decompensated heart failure, uncorrected abnormal K + or Mg ++ blood levels, or severe left ventricular hypertrophy. 4. Uncomplicated infection of skin and soft tissues. 5. Self-limited infection. 6. Superinfected eczema, hidradenitis suppurativa or other chronic medical conditions in which inflammation may be a prominent feature for a prolonged period even after successful bacterial eradication. 7. Concurrent infections of non-removable prosthetic materials. 8. Concurrent presence of osteomyelitis, endocarditis or other deep tissue infection other than skin and soft tissue infection. 9. Infections by a Gram-positive microorganism with proven resistance to vancomycin or Gram-negative with proven resistance to aztreonam. 10. Burns that affect> 20% of the body surface or third degree / full thickness, diabetic foot ulcers, ischemic ulcers / wounds, necrotizing fasciitis, gas gangrene or mediastinitis, individuals with severe neutropenia or individuals in whom development is anticipated of it during the study treatment period. 11. Infected with HIV with a proven CD4 count <100 cells / mm3 during the last 6 months. 12. Known hypersensitivity or intolerance to the study medications or to the excipients of their formulations. 13. a) Women of childbearing age if they are pregnant, breastfeeding or unable to use a highly effective method of birth control. b) Male patients should agree to the use of a medically acceptable method of birth control for at least three months after the last dose of study medication. 14. Previous inclusion in a clinical study with telavancin. 15. Treatment with another medication / experimental device in the 30 days prior to entry into the study. 16. Patients in shock or with little chance of survival during the treatment and evaluation period. 17. Patients unable to comply with the study procedures. 18. Any other condition that, in the opinion of the Investigator, may confuse or interfere with the evaluation of the safety or efficacy of the experimental drug or prevent compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Measure:Clinical response Timepoints:At the final visit of the treatment: Days 7 to 14 and at the follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Culture of the primary site of infection. Clinical evaluation Measure:Microbiological response. Global therapeutic response (combination of clinical response and microbiological response). Timepoints:At the beginning of the treatment, in the final visit of the treatment: Days 7 to 14 and in the follow-up visit. ; Outcome name:Clinical evaluation Measure:Treatment duration. Time elapsed until the resolution of the fever. Total score of signs and symptoms. Timepoints:At the beginning of the treatment, in the final visit of the treatment: Days 7 to 14 and in the follow-up visit. ; Outcome name:Evaluation of adverse events during clinical evaluation. 12-lead ECG. Hematological tests: hematocrit, hemoglobin, leukocyte count with differential formula by microscopic examination with percentage of immature neutrophils (in the arch), mature neutrophils and eosinophils, and platelet count. Serum chemistry: potassium, magnesium, blood urea nitrogen (BUN), creatinine, total bilirubin, alkaline phosphatase, LDH, ALT (SGPT), AST (SGOT). Complete analysis of urine. Measure:Safety of treatment: Adverse events. Lab results. Timepoints:Clinical evaluation: In the final visit of the treatment: Days 7 to 14 and in the follow-up visit. ECG and laboratory tests At the start of treatment, every 3 days, at the final visit of the treatment: Days 7 to 14 and at the follow-up visit. | — |
Countries
Italy, Lithuania, Peru, United Kindgdom
Outcome results
None listed