Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial
— VanCatOfficial 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
Verified date | April 2021 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of central line-associated bloodstream infections | Definition according to the National Healthcare Safety Network (NHSN - CDC) Patient Safety Component Manual 2021 | from blood cultures drawn before replacement and at 48 and 96 hours | |
Other | Blood culture | positivity of blood cultures | from blood cultures drawn before replacement and at 48 and 96 hours | |
Other | Vancomycin level in plasma | Vancomycin level (mg/L) in plasma after 24 hours | 24 hours after administration | |
Other | Incidence of acute kidney injury | Incidence of new or worsening acute kidney injury according to the definition and classification of the KDIGO 2012 guidelines | 28 days | |
Other | Hypersensitivity reaction to Vancomycin | Hypersensitivity reaction in the following 6 hours after vancomycin administration/catether replacement. Hypersensitivity reaction is defined as any new of the following symptoms: flushing, erythema, pruritus, pains or muscle spasms in the back or chest, dyspnea or hypotension. | 6 hours after catheter replacement | |
Primary | 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) | 96 hours after catheter replacement | |
Secondary | Negativity of blood culture results | Negativity of blood culture results after 48 hours, 96 hours and both | 48 hours and 96 hours after catheter replacement | |
Secondary | Reduction of C-reactive protein | Absolute reduction of C-reactive protein (mg/dl) in plasma | 48 hours and 96 hours after catheter replacement | |
Secondary | Reduction of Procalcitonin | Absolute reduction of Procalcitonin (mcg/L) in plasma | 48 hours and 96 hours after catheter replacement | |
Secondary | Reduction of IL-6 | Absolute reduction of IL-6 (ng/L) in plasma | 48 hours and 96 hours after catheter replacement | |
Secondary | Reduction of white blood cell count | Absolute reduction of white blood cell count (G/L) | 48 hours and 96 hours after catheter replacement | |
Secondary | 28-day survival | Survival after a follow-up of 28 days or until hospital discharge | 28 days | |
Secondary | ICU-free days at day 28 | Cumulative days not admitted to the intensive care unit in patients alive at day 28 | 28 days | |
Secondary | Vasopressor-free days at day 28 | Cumulative days of no vasopressor therapy in patients alive at day 28 | 28 days | |
Secondary | Invasive mechanical ventilation-free days at day 28 | Cumulative days of no invasive mechanical ventilation in patients alive at day 28 | 28 days | |
Secondary | Antibiotic-free days at day 28 | Cumulative days of no antibiotic therapy in patients alive at day 28 | 28 days |
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