inezolid vs Vancomycin/Cefazolin in the treatment of hemodialysis patients with catheter-related gram-positive bloodstream infections - N/A

Phase 1

• Conditions: Catheter-related Gram-positive bloodstream infections.; MedDRA version: 7.1Level: LLTClassification code 10007810

• Registration Number: EUCTR2004-005159-32-SK
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-31
• Study Completion: 2006-09-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

1. Male or female 18 years of age or older and = 40 kg body weight.
2. 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)
ORB) A body temperature of = 38.0 oC or < 36 oC (oral equivalent).
ORC) 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.
3. 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 ³ 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
4. Patients on hemodialysis with tunneled or nontunneled catheters including antibiotic coated catheters. Patients may have more than one concurrent catheterPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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.
2. 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.
3. Patients in whom the infected catheter cannot be removed.
4. 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.
5. 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.
6. Identification of a pathogen resistant to linezolid or vancomycin.
7. Patients who are unlikely to survive through the treatment period and evaluation.
8. 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.
9. Previous enrollment in this protocol.
10. Hypersensitivity to linezolid, vancomycin, gentamicin or one of their excipients (or aztreonam if non-bacteremic Gram-negative coverage is required).
11. Concurrent use of another investigational medication or use within 30 days of study entry.
12. Patients with pressor and fluid-resistant hemodynamic compromise or pulmonary embolism.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified