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

Last updated on March 14, 2019

Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21201-1524 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacteremia, Gram-Positive Bacterial Infections
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
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 torr; *White blood count >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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- 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

- Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary embolism

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


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