Effect of Vancomycin After Catheter Replacement
- Conditions
- Central Line-associated Bloodstream Infection (CLABSI)Catheter-related Bloodstream Infection
- Interventions
- Registration Number
- NCT04856878
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Vancomycin Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg
- Primary Outcome Measures
Name Time Method Resolution of infection 96 hours after catheter replacement 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)
- Secondary Outcome Measures
Name Time Method Reduction of IL-6 48 hours and 96 hours after catheter replacement Absolute reduction of IL-6 (ng/L) in plasma
Reduction of C-reactive protein 48 hours and 96 hours after catheter replacement Absolute reduction of C-reactive protein (mg/dl) in plasma
Antibiotic-free days at day 28 28 days Cumulative days of no antibiotic therapy in patients alive at day 28
Negativity of blood culture results 48 hours and 96 hours after catheter replacement Negativity of blood culture results after 48 hours, 96 hours and both
Reduction of white blood cell count 48 hours and 96 hours after catheter replacement Absolute reduction of white blood cell count (G/L)
Vasopressor-free days at day 28 28 days Cumulative days of no vasopressor therapy in patients alive at day 28
Reduction of Procalcitonin 48 hours and 96 hours after catheter replacement Absolute reduction of Procalcitonin (mcg/L) in plasma
28-day survival 28 days Survival after a follow-up of 28 days or until hospital discharge
ICU-free days at day 28 28 days Cumulative days not admitted to the intensive care unit in patients alive at day 28
Invasive mechanical ventilation-free days at day 28 28 days Cumulative days of no invasive mechanical ventilation in patients alive at day 28