Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
NCT00108433
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections | |||
Official Title ICMJE | Linezolid vs Vancomycin/Cefazolin in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections | |||
Brief Summary | This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria). | |||
Detailed Description | 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 61 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | September 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Colombia, India, Israel, Italy, Poland, Slovakia, United States | |||
Removed Location Countries | Belgium, Germany, Greece, Guatemala, Panama, Peru, Portugal, Singapore | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00108433 | |||
Other Study ID Numbers ICMJE | A5951105 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |