Effect of Vancomycin After Catheter Replacement

NCT04856878 | Unknown Phase 4

• 1 other identifier: SD02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Negativity of blood culture results

  48 hours and 96 hours after catheter replacement

• Reduction of C-reactive protein

  48 hours and 96 hours after catheter replacement

• Reduction of Procalcitonin

  48 hours and 96 hours after catheter replacement

• Reduction of IL-6

  48 hours and 96 hours after catheter replacement

• Reduction of white blood cell count

  48 hours and 96 hours after catheter replacement

Other Outcomes (5)

• Incidence of central line-associated bloodstream infections

  from blood cultures drawn before replacement and at 48 and 96 hours

• Blood culture

  from blood cultures drawn before replacement and at 48 and 96 hours

• Vancomycin level in plasma

  24 hours after administration

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Vancomycin

Control

NO INTERVENTION

Standard of care (SOC)

Interventions

Vancomycin DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Conditions

Sepsis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 23, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2021

Record last verified: 2021-04