Effect of Vancomycin After Catheter Replacement

Central Line-associated Bloodstream Infection (CLABSI) Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04856878
• Other study ID #: SD02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Catheter-related Bloodstream Infection
• Central Line-associated Bloodstream Infection (CLABSI)
• Communicable Diseases
• Infection
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

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