inezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections

Not Applicable

• Conditions: -T802 Infections following infusion, transfusion and therapeutic injection; Infections following infusion, transfusion and therapeutic injection; T802

• Registration Number: PER-033-05
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

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 <36 ° C. C) A positive blood culture for Gram-positive microorganisms.
3. Presence of at least one of the following systemic signs of infection: A) Hypotension. B) Tachycardia. C) Tachypnea. D) Leukocyte count> 10,000 cells / mm3 or <4,000 cells / mm3, or with a differential count showing> 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Peripheral blood. Catheter blood. Exudate culture of the insertion site. Culture of abscess aspiration. End catheter culture.<br>Measure:Result of microbiological cultures to check healing<br>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).<br>Catheter blood. Exudate culture of the insertion site. Culture of abscess aspiration. End catheter culture.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical efficacy Incidence of complications: Clinical evaluation<br>Rate of eradication of individual pathogens. Time for the eradication of bacteria: peripheral blood and catheter cultures.<br>Eradication of nasal colonization: Nasal swab culture.<br>Measure:Clinical efficacy Incidence of complications. Rate of eradication of individual pathogens. Time for the eradication of bacteria. Eradication of nasal colonization.<br>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).<br>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).<br>Catheter culture: At the start of treatment.<br>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<br>