- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108433
Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections
June 28, 2012 updated by: Pfizer
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
61
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Atlantico
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Barranquilla, Atlantico, Colombia
- Pfizer Investigational Site
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Cundinamarca
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Bogota, Cundinamarca, Colombia
- Pfizer Investigational Site
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D.C
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Bogota, D.C, Colombia
- Pfizer Investigational Site
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Andhra Pradesh
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Hyderbad, Andhra Pradesh, India, 500 082
- Pfizer Investigational Site
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Delhi
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New Delhi, Delhi, India, 110 044
- Pfizer Investigational Site
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Karnataka
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Bangalore, Karnataka, India, 560 034
- Pfizer Investigational Site
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Bangalore, Karnataka, India, 560 054
- Pfizer Investigational Site
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Punjab
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Chandigarh, Punjab, India, 160 012
- Pfizer Investigational Site
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600 004
- Pfizer Investigational Site
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Tel-Aviv, Israel, 64239
- Pfizer Investigational Site
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Imperia, Italy, 18100
- Pfizer Investigational Site
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Czestochowa, Poland, 42-200
- Pfizer Investigational Site
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Banska Bystrica, Slovakia, 975 17
- Pfizer Investigational Site
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Nitra, Slovakia, 950 01
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21201
- Pfizer Investigational Site
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Baltimore, Maryland, United States, 21230
- Pfizer Investigational Site
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Baltimore, Maryland, United States, 21201-1524
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Time Frame: Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
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Microbiological response assessed at participant level.
Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.
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Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment
Time Frame: EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)
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Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification.
Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.
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EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)
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Number of Participants With Complications During Therapy
Time Frame: LTFU visit (6 to 8 weeks after the last dose of study medication)
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Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.
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LTFU visit (6 to 8 weeks after the last dose of study medication)
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Percentage of Pathogens Eradicated
Time Frame: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
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Eradication included Documented or Presumed Eradication of the given pathogen.
Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.
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STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
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Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization
Time Frame: STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
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Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.
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STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
April 15, 2005
First Submitted That Met QC Criteria
April 15, 2005
First Posted (Estimate)
April 18, 2005
Study Record Updates
Last Update Posted (Estimate)
August 7, 2012
Last Update Submitted That Met QC Criteria
June 28, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Bacterial Infections and Mycoses
- Sepsis
- Infections
- Communicable Diseases
- Bacteremia
- Bacterial Infections
- Gram-Positive Bacterial Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Vancomycin
- Linezolid
- Cefazolin
Other Study ID Numbers
- A5951105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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