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

NCT00108433 | Terminated Phase 3 Results

• 1 other identifier: A5951105
• Study Type: interventional
• Target: 61
• Locations: 7 countries
• Sites: 17

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).

Conditions

Bacteremia; Gram-Positive Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit

  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.

  Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)

Secondary Outcomes (4)

• Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment

  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)

• Number of Participants With Complications During Therapy

  LTFU visit (6 to 8 weeks after the last dose of study medication)

• Percentage of Pathogens Eradicated

  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)

• Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization

  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)

Interventions

Cefazolin IV DRUG

Linezolid IV DRUG

Vancomycin (IV) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

Pfizer Investigational Site

Baltimore, Maryland, 21201-1524, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21230, United States

Location

Pfizer Investigational Site

Barranquilla, Atlántico, Colombia

Location

Pfizer Investigational Site

Bogota, Cundinamarca, 0, Colombia

Location

Pfizer Investigational Site

Bogotá, D.C, Colombia

Location

Pfizer Investigational Site

Hyderbad, Andhra Pradesh, 500 082, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 054, India

Location

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, 110 044, India

Location

Pfizer Investigational Site

Chandigarh, Punjab, 160 012, India

Location

Pfizer Investigational Site

Chennai, Tamil Nadu, 600 004, India

Location

Pfizer Investigational Site

Tel Aviv, 64239, Israel

Location

Pfizer Investigational Site

Imperia, 18100, Italy

Location

Pfizer Investigational Site

Częstochowa, 42-200, Poland

Location

Pfizer Investigational Site

Banská Bystrica, Slovakia, 975 17, Slovakia

Location

Pfizer Investigational Site

Nitra, 950 01, Slovakia

Location

Related Publications (1)

• Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.

  PMID: 35363884 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bacteremia; Gram-Positive Bacterial Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Efficacy results were not reported because the study was prematurely terminated.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2005
• First Posted: April 18, 2005
• Study Start: September 1, 2005
• Study Completion: September 1, 2006
• Last Updated: August 7, 2012
• Results First Posted: August 7, 2012

Record last verified: 2012-06

Locations

SL (2); PL (1); CO (3); IL (1); IN (6); IT (1); US (3)