Clinical trial NCT04856878: Effect of Vancomycin After Catheter Replacement
Official title: Effect of Single-dose Vancomycin After Catheter Replacement for Suspected Central Line-associated Bloodstream Infection (CLABSI) on Resolution of Infection in Critically Ill Patients: A Single Center Randomized Open Label Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Central Line-associated Bloodstream Infection (CLABSI)
Catheter-related Bloodstream Infection
Keywords: Central Line-associated Bloodstream Infection
Catheter-related Bloodstream Infection
Vancomycin
Critical Care
Bloodstream Infection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of infection
timeFrame: 96 hours after catheter replacement
Secondary outcomes:
measure: Negativity of blood culture results
timeFrame: 48 hours and 96 hours after catheter replacement
measure: Reduction of C-reactive protein
timeFrame: 48 hours and 96 hours after catheter replacement
measure: Reduction of Procalcitonin
timeFrame: 48 hours and 96 hours after catheter replacement
measure: Reduction of IL-6
timeFrame: 48 hours and 96 hours after catheter replacement
measure: Reduction of white blood cell count
timeFrame: 48 hours and 96 hours after catheter replacement
measure: 28-day survival
timeFrame: 28 days
measure: ICU-free days at day 28
timeFrame: 28 days
measure: Vasopressor-free days at day 28
timeFrame: 28 days
measure: Invasive mechanical ventilation-free days at day 28
timeFrame: 28 days
measure: Antibiotic-free days at day 28
timeFrame: 28 days
Other outcomes:
measure: Incidence of central line-associated bloodstream infections
timeFrame: from blood cultures drawn before replacement and at 48 and 96 hours
measure: Blood culture
timeFrame: from blood cultures drawn before replacement and at 48 and 96 hours
measure: Vancomycin level in plasma
timeFrame: 24 hours after administration
measure: Incidence of acute kidney injury
timeFrame: 28 days
measure: Hypersensitivity reaction to Vancomycin
timeFrame: 6 hours after catheter replacement
Locations:
Study officials:
References: