None listed
Conditions
Interventions
Group 1 Type of group
Linezolid may be administered IV or PO according to clinical criteria:
- Linezolid IV 600 mg in 300 ml each day. Diluent contains: dextrose, sodium citrate, citric acid and water for injection.
- Linezolid PO 600 mg every day. Inactive ingredients: 600 mg with a coating film. The inactive ingredients are the following: corn starch, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycollate, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium
Patients in this group will begin treatment with Vancomycin 1g in vials IV every 24 hours, until the results of the cultures are obtained. If MSRA is found, the same regime will continue.
If organisms that are sensitive to methicillin are found, the switch to Cefazolin should be made in 1 g vials every 24 hours.
The total duration of treatment will be 21 to 28 days according to clinical evaluation.
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 18 years of age or older and with a body weight> 40 Kg. 2. Patients with end-stage renal disease undergoing hemodialysis, with the following: A) Signs and symptoms of a localized infection related to catheters. B) A body temperature> 38.0 ° C or 10,000 cells / mm3 or 10% abasted neutrophils. 4. Patients undergoing hemodialysis with tunneled or non-tunneled catheters. 5. Patients who are willing and able to comply with scheduled visits, plan for treatment, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Bloodstream infections related to catheters caused by Gram-negative bacteria, fungi, mixed cultures of Gram-negative bacteria and Gram-positive bacteria or mixed cultures with Gram positive / negative bacteria and fungi. 2. Patients with evidence of other infections that result in bacteremia. 3. Patients in whom the infected catheter can not be removed. 4. Patients with permanent intravascular devices. 5. Women with potential to have family who are not able or who do not wish to take adequate contraceptive precautions, who have a positive result in a test to diagnose the pregnancy within 24 hours before entering the study, that is known are pregnant, or are currently breastfeeding an infant. 6. Identification of a pathogen resistant to linezolid or vancomycin. 7. Patients who are unlikely to survive throughout the treatment and evaluation periods. 8. Administration of a glycopeptide antibiotic within 5 days before enrollment. 9. Previous enrollment in the present protocol. 10. Hypersensitivity to linezolid, vancomycin, gentamicin or to any of its excipients. 11. Concurrent use of another medication in research or use within 30 days of entering the study. 12. Patients with hemodynamic compromise resistant to pressors and fluids, or with pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Peripheral blood. Catheter blood. Exudate culture of the insertion site. Culture of abscess aspiration. End catheter culture. Measure:Result of microbiological cultures to check healing Timepoints:Peripheral blood: At the beginning, days 3 and 7, at the end of the treatment. And on short-term follow-up visits (weeks 2 - 3) and long-term follow-up visits (weeks 6 - 8). Catheter blood. Exudate culture of the insertion site. Culture of abscess aspiration. End catheter culture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical efficacy Incidence of complications: Clinical evaluation Rate of eradication of individual pathogens. Time for the eradication of bacteria: peripheral blood and catheter cultures. Eradication of nasal colonization: Nasal swab culture. Measure:Clinical efficacy Incidence of complications. Rate of eradication of individual pathogens. Time for the eradication of bacteria. Eradication of nasal colonization. Timepoints:Clinical evaluation: At the beginning and at the end of the treatment. In addition to during follow-up visits in the short term (Weeks 2-3) and in the long term (Weeks 6-8). Peripheral blood cultures: Days 3 and 5. In addition to during follow-up visits in the short term (Weeks 2-3) and in the long term (Weeks 6-8). Catheter culture: At the start of treatment. Nasal swab culture: Days 7 and 21. In addition to during short-term follow-up visits (Weeks 2-3) and long-term follow-up visits | — |
Countries
Belgium, Colombia, Germany, Greece, Guatemala, India, Israel, Italy, Panama, Poland, Portugal, Singapore, Slovakia, United States
Outcome results
None listed