Effect of Vancomycin After Catheter Replacement

University of Zurich100 enrolled

Overview

Randomized controlled trial of the effect of a single-dose intravenous Vancomycin after catheter replacement for suspected central line-associated bloodstream infection on resolution of infection in critically ill patients.

Patients on the local intensive care unit with suspicion of central line-associated bloodstream infection will be randomized to standard of care consisting of catheter replacement and blood and catheter tip cultures and to standard of care plus a single-dose vancomycin. The effect of the intervention on resolution of humoral inflammation and negativity of blood cultures will be assessed after 48 and 96 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Central Line-associated Bloodstream Infection (CLABSI)Catheter-related Bloodstream Infection

Interventions

VancomycinDRUG

The investigational drug vancomycin is administered intravenously through a newly inserted peripheral or central venous catheter directly after removal of the 'old' catheters. The investigational drug is administered with a volume of 500ml normal saline (NaCl 0.9%) with a rate of maximal 1g per hour.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Suspected central line-associated bloodstram infection defined as: * Catheterization with a non-tunneled CVC and * Clinical signs of local catheter infection or any increase in humoral inflammatory markers (PCT, CRP, WBC) or elevated body temperature ≥ 38.3°C not otherwise explained. Baseline CRP at screening ≥ 100 mg/L Exclusion Criteria: * known positive blood cultures at the time of randomization * High risk situation warranting immediate empiric antibiotic therapy: * endovascular implant (prosthetic valve, pacemaker, vascular graft) * high-risk for endocarditis warranting endocarditis-prophylaxis * Septic shock * Catheter replacement not feasible or no further indication for central venous catheterization * Known hypersensitivity to vancomycin or any component of the formulation. * Administration of Vancomycin, Teicoplanin, Daptomycin or Linezolid \<48 hours before enrolment. * Enrolment in another clinical study * Pregnancy

Outcomes

Primary Outcomes

Resolution of infection

Composite endpoint of absolute reduction of C-reactive protein and negativity of blood culture results at 48 and 96 hours (combinated with augmented binary method)

Time frame: 96 hours after catheter replacement