- To be eligible for this study, a patient must provide informed consent and must meet
all of the following criteria. No study procedures, including any baseline tests,
should be performed until the patient (or parent/legally acceptable representative,
if appropriate) legally signs the informed consent form.
- Male or female, 18 years of age or older and >= 40 kg body weight
- 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); OR B) A body temperature of >= 38.0 C
or Gram-positive isolate is S. aureus, it must be cultured from at least 1 culture
bottle from either the peripheral set or the catheter set of culture bottles. For all
other Gram-positive pathogens (eg, coagulase-negative staphylococci), isolates need
to be cultured from at least 2 culture bottles of which one must be from the
peripheral set. There must be no other obvious source of the bacteremia
- Presence of at least one of the following systemic signs of infection (may be
obtained up to 24 hours prior to baseline): *Hypotension, defined as systolic blood
pressure = 40 mmHg from the patient's baseline, in the
absence of other causes for hypotension; *Tachycardia defined as a pulse rate > 90
beats per minute; *Tachypnea defined as a respiratory rate > 20 breaths per minute or
PACO2 10,000 cells/mm3 or differential count showing >10% band neutrophil forms.
- Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic
coated hemodialysis catheters. Patients may have more than one concurrent catheter.
- Patients who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures
- Patients presenting with any of the following will not be included in this study:
- 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
- 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
- Patients in whom the infected catheter cannot be removed
- 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
- 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
- Identification of a pathogen resistant to linezolid or vancomycin
- Patients who are unlikely to survive through the treatment period and evaluation
- 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
- Previous enrollment in this protocol
- Hypersensitivity to linezolid, vancomycin, gentamicin or one of their excipients (or
aztreonam if non-bacteremic Gram-negative coverage is required)
- Concurrent use of another investigational medication or use within 30 days of study
entry
- Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary
embolism