Effect of Vancomycin After Catheter Replacement (VanCat)
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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