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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Baltimore, Maryland, 21201-1524 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacteremia, Gram-Positive Bacterial Infections
Sex
Females and Males
Age
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.
Show details

- 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.
Show details

- 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

NCT00108433
Pfizer
Terminated
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections

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Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bacteremia
  • Gram-Positive Bacterial Infections
  • Drug: Cefazolin IV
  • Drug: Linezolid IV
  • Drug: Vancomycin (IV)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
61
September 2006
Not Provided

Inclusion Criteria:

  • 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 < 36.0 C (oral equivalent); OR C) A Gram-positive blood culture. If the 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 <90 mmHg or its reduction by >= 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 <32 torr; *White blood count >10,000 cells/mm3 or < 4,000 cells/mm3, or with a 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:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Colombia,   India,   Israel,   Italy,   Poland,   Slovakia,   United States
Belgium,   Germany,   Greece,   Guatemala,   Panama,   Peru,   Portugal,   Singapore
 
NCT00108433
A5951105
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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