Effect of Vancomycin After Catheter Replacement

NCT ID: NCT04856878

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-12-31

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.

Conditions

Central Line-associated Bloodstream Infection (CLABSI); Catheter-related Bloodstream Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: 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.

Control

Standard of care (SOC)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SD02

Identifier Type: -

Identifier Source: org_study_id