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

NCT ID: NCT00108433

Last Updated: 2012-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-09-30

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.

Conditions

Bacteremia; Gram-Positive Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cefazolin IV

Intervention Type: DRUG

Linezolid IV

Intervention Type: DRUG

Vancomycin (IV)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Hyderbad, Andhra Pradesh, India

Pfizer Investigational Site

Bangalore, Karnataka, India

Pfizer Investigational Site

Bangalore, Karnataka, India

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Pfizer Investigational Site

Tel Aviv, , Israel

Pfizer Investigational Site

Imperia, , Italy

Pfizer Investigational Site

Częstochowa, , Poland

Pfizer Investigational Site

New Delhi, National Capital Territory of Delhi, India

Pfizer Investigational Site

Chandigarh, Punjab, India

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Baltimore, Maryland, United States

Pfizer Investigational Site

Barranquilla, Atlántico, Colombia

Pfizer Investigational Site

Bogota, Cundinamarca, Colombia

Pfizer Investigational Site

Bogotá, D.C, Colombia

Pfizer Investigational Site

Banská Bystrica, Slovakia, Slovakia

Pfizer Investigational Site

Nitra, , Slovakia

Countries

Belgium; Germany; Greece; Guatemala; Panama; Peru; Portugal; Singapore; United States; Colombia; India; Israel; Italy; Poland; Slovakia

References

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.

Reference Type: DERIVED

PMID: 35363884 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951105&StudyName=Linezolid%20in%20the%20Treatment%20of%20Hemodialysis%20Patients%20with%20Catheter-Related%20Gram-Positive%20Bloodstream%20Infections

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

Other Identifiers

A5951105

Identifier Type: -

Identifier Source: org_study_id