Catheter-related Gram-positive bloodstream infections. MedDRA version: 7.1 Level: LLT Classification code 10007810
Conditions
Interventions
Trade Name: Zyvox
Zyvoxid
Gabriox
Product Name: Linezolid
Product Code: PNU-10076
Pharmaceutical Form: Tablet
INN or Proposed INN: Linezolid
Other descriptive name: (-)-N-[[(S)-3-(3-Fluoro-4-morpholin
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 18 years of age or older and = 40 kg body weight. 2. End-stage renal disease patients on hemodialysis with: A) Signs and symptoms of a localized catheter-related infection (eg. tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site) ORB) A body temperature of = 38.0 oC or 90 beats per minute- Tachypnea defined as a respiratory rate > 20 breaths per minute or PACO2 10,000 cells/mm3 or 10% band neutrophil forms 4. Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic coated catheters. Patients may have more than one concurrent catheterPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Catheter-related bloodstream infections caused by Gram-negative bacteria, fungi, mixed cultures of Gram-negative bacteria and Gram-positive bacteria or mixed cultures of Gram-positive/negative bacteria and fungi. 2. Patients with evidence of other infections resulting in bacteremia, such as clinical or radiographic signs of osteomyelitis, endocarditis, skin/skin structure infection, pneumonia, urinary tract infection, joint infection, intraabdominal infection, septic thrombophlebitis or other infection. 3. Patients in whom the infected catheter cannot be removed. 4. Patients with permanent intravascular devices such as artificial vascular grafts, implantable pacemakers or defibrillators; intra-aortic balloon pumps, and left ventricular assist device; intravascular transplants such as prosthetic cardiac valves; or non-intravascular devices such as peritoneal dialysis catheters; or neurosurgical devices such as ventriculo-peritoneal shunts, intra-cranial pressure monitors, or epidural catheters, prosthetic cardiac valves, prosthetic vascular grafts, or other internal prosthesis. 5. Females of child-bearing potential who are unable or unwilling to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant. 6. Identification of a pathogen resistant to linezolid or vancomycin. 7. Patients who are unlikely to survive through the treatment period and evaluation. 8. Administration of a glycopeptide antibiotic within 5 days prior to enrollment. Administration of other potentially effective systemic Gram-positive antibiotics for more than 48 hours within 72 hours prior to enrollment unless the pathogen showed drug resistance. 9. Previous enrollment in this protocol. 10. Hypersensitivity to linezolid, vancomycin, gentamicin or one of their excipients (or aztreonam if non-bacteremic Gram-negative coverage is required). 11. Concurrent use of another investigational medication or use within 30 days of study entry. 12. Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Microbiological efficacy of linezolid compared to vancomycin/cefazolin.;Secondary Objective: 1. Clinical efficacy of linezolid compared to vancomycin/cefazolin 2. Incidence of late metastatic sequelae associated with Gram-positive infections in patients treated with linezolid or vancomycin/cefazolin. 3. Pathogen eradication 4. Time to eradication of bacteremia 5. Eradication of Staphylococcus aureus nasal colonization 6. Safety and tolerance.;Primary end point(s): The primary endpoint used to assess the primary objective will be patient microbiologic outcome at the Test of Cure (TOC) visit. | — |
Countries
Germany, Italy, Slovakia, Spain
Outcome results
None listed