Back to resultsEffect of Vancomycin After Catheter Replacement (VanCat)
Primary Purpose
Central Line-associated Bloodstream Infection (CLABSI), Catheter-related Bloodstream Infection
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vancomycin
Sponsored by
About this trial
This is an interventional treatment trial for Central Line-associated Bloodstream Infection (CLABSI) focused on measuring Central Line-associated Bloodstream Infection, Catheter-related Bloodstream Infection, Vancomycin, Critical Care, Bloodstream Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg
Standard of care (SOC)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Negativity of blood culture results
Negativity of blood culture results after 48 hours, 96 hours and both
Reduction of C-reactive protein
Absolute reduction of C-reactive protein (mg/dl) in plasma
Reduction of Procalcitonin
Absolute reduction of Procalcitonin (mcg/L) in plasma
Reduction of IL-6
Absolute reduction of IL-6 (ng/L) in plasma
Reduction of white blood cell count
Absolute reduction of white blood cell count (G/L)
28-day survival
Survival after a follow-up of 28 days or until hospital discharge
ICU-free days at day 28
Cumulative days not admitted to the intensive care unit in patients alive at day 28
Vasopressor-free days at day 28
Cumulative days of no vasopressor therapy in patients alive at day 28
Invasive mechanical ventilation-free days at day 28
Cumulative days of no invasive mechanical ventilation in patients alive at day 28
Antibiotic-free days at day 28
Cumulative days of no antibiotic therapy in patients alive at day 28
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04856878
Brief Title
Effect of Vancomycin After Catheter Replacement
Acronym
VanCat
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care (SOC)
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resolution of infection
Description
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
Secondary Outcome Measure Information:
Title
Negativity of blood culture results
Description
Negativity of blood culture results after 48 hours, 96 hours and both
Time Frame
48 hours and 96 hours after catheter replacement
Title
Reduction of C-reactive protein
Description
Absolute reduction of C-reactive protein (mg/dl) in plasma
Time Frame
48 hours and 96 hours after catheter replacement
Title
Reduction of Procalcitonin
Description
Absolute reduction of Procalcitonin (mcg/L) in plasma
Time Frame
48 hours and 96 hours after catheter replacement
Title
Reduction of IL-6
Description
Absolute reduction of IL-6 (ng/L) in plasma
Time Frame
48 hours and 96 hours after catheter replacement
Title
Reduction of white blood cell count
Description
Absolute reduction of white blood cell count (G/L)
Time Frame
48 hours and 96 hours after catheter replacement
Title
28-day survival
Description
Survival after a follow-up of 28 days or until hospital discharge
Time Frame
28 days
Title
ICU-free days at day 28
Description
Cumulative days not admitted to the intensive care unit in patients alive at day 28
Time Frame
28 days
Title
Vasopressor-free days at day 28
Description
Cumulative days of no vasopressor therapy in patients alive at day 28
Time Frame
28 days
Title
Invasive mechanical ventilation-free days at day 28
Description
Cumulative days of no invasive mechanical ventilation in patients alive at day 28
Time Frame
28 days
Title
Antibiotic-free days at day 28
Description
Cumulative days of no antibiotic therapy in patients alive at day 28
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Incidence of central line-associated bloodstream infections
Description
Definition according to the National Healthcare Safety Network (NHSN - CDC) Patient Safety Component Manual 2021
Time Frame
from blood cultures drawn before replacement and at 48 and 96 hours
Title
Blood culture
Description
positivity of blood cultures
Time Frame
from blood cultures drawn before replacement and at 48 and 96 hours
Title
Vancomycin level in plasma
Description
Vancomycin level (mg/L) in plasma after 24 hours
Time Frame
24 hours after administration
Title
Incidence of acute kidney injury
Description
Incidence of new or worsening acute kidney injury according to the definition and classification of the KDIGO 2012 guidelines
Time Frame
28 days
Title
Hypersensitivity reaction to Vancomycin
Description
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.
Time Frame
6 hours after catheter replacement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Vancomycin After Catheter Replacement
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