VanCat: Effect of Vancomycin After Catheter Replacement

Sponsor

University of Zurich (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04856878

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Line-associated Bloodstream Infection (CLABSI) Catheter-related Bloodstream Infection	Drug: Vancomycin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg	Drug: Vancomycin 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.
No Intervention: Control Standard of care (SOC)

Arm

Intervention/Treatment

Experimental: Intervention

Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg

Drug: Vancomycin

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.

No Intervention: Control

Standard of care (SOC)

Outcome Measures

Primary Outcome Measures

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

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 C-reactive protein [48 hours and 96 hours after catheter replacement]
Absolute reduction of C-reactive protein (mg/dl) in plasma
Reduction of Procalcitonin [48 hours and 96 hours after catheter replacement]
Absolute reduction of Procalcitonin (mcg/L) in plasma
Reduction of IL-6 [48 hours and 96 hours after catheter replacement]
Absolute reduction of IL-6 (ng/L) in plasma
Reduction of white blood cell count [48 hours and 96 hours after catheter replacement]
Absolute reduction of white blood cell count (G/L)
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
Vasopressor-free days at day 28 [28 days]
Cumulative days of no vasopressor therapy 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
Antibiotic-free days at day 28 [28 days]
Cumulative days of no antibiotic therapy in patients alive at day 28

Other Outcome Measures

Incidence of central line-associated bloodstream infections [from blood cultures drawn before replacement and at 48 and 96 hours]
Definition according to the National Healthcare Safety Network (NHSN - CDC) Patient Safety Component Manual 2021
Blood culture [from blood cultures drawn before replacement and at 48 and 96 hours]
positivity of blood cultures
Vancomycin level in plasma [24 hours after administration]
Vancomycin level (mg/L) in plasma after 24 hours
Incidence of acute kidney injury [28 days]
Incidence of new or worsening acute kidney injury according to the definition and classification of the KDIGO 2012 guidelines
Hypersensitivity reaction to Vancomycin [6 hours after catheter replacement]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy 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