Central Line-associated Bloodstream Infection (CLABSI)Phase 4VanCatNCT04856878
Effect of Vancomycin After Catheter Replacement
A Phase 4 study testing Vancomycin in people with Central Line-associated Bloodstream Infection (CLABSI) and Catheter-related Bloodstream Infection, run by University of Zurich.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI), Catheter-related Bloodstream Infection
- What is being tested?
- Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
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.
Read the 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
- Being tested
- Vancomycin
- Keywords
- Central Line-associated Bloodstream Infection, Catheter-related Bloodstream Infection, Vancomycin, Critical Care, Bloodstream Infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard of care (SOC) + single-dose intravenous vancomycin 15mg/kg Receives: Drug: Vancomycin |
| Control | No intervention | Standard of care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 96 hours after catheter replacement
Secondary outcomes (10)
Negativity of blood culture results
Negativity of blood culture results after 48 hours, 96 hours and both
Measured: 48 hours and 96 hours after catheter replacement
Reduction of C-reactive protein
Absolute reduction of C-reactive protein (mg/dl) in plasma
Measured: 48 hours and 96 hours after catheter replacement
Reduction of Procalcitonin
Absolute reduction of Procalcitonin (mcg/L) in plasma
Measured: 48 hours and 96 hours after catheter replacement
Reduction of IL-6
Absolute reduction of IL-6 (ng/L) in plasma
Measured: 48 hours and 96 hours after catheter replacement
Reduction of white blood cell count
Absolute reduction of white blood cell count (G/L)
Measured: 48 hours and 96 hours after catheter replacement
28-day survival
Survival after a follow-up of 28 days or until hospital discharge
Measured: 28 days
ICU-free days at day 28
Cumulative days not admitted to the intensive care unit in patients alive at day 28
Measured: 28 days
Vasopressor-free days at day 28
Cumulative days of no vasopressor therapy in patients alive at day 28
Measured: 28 days
Invasive mechanical ventilation-free days at day 28
Cumulative days of no invasive mechanical ventilation in patients alive at day 28
Measured: 28 days
Antibiotic-free days at day 28
Cumulative days of no antibiotic therapy in patients alive at day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856878
- Sponsor's protocol ID
- SD02
- Acronym
- VanCat
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04856878
- Acronym / sponsor ID
- VanCat / SD02
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: VancomycinStandard of care (SOC) + single-dose intravenous vancomycin 15mg/kg |
| Control | No intervention | –Standard of care (SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinThe 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. | Drug | Intervention |
Primary outcome
Resolution of infection
Time frame: 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)
10 secondary outcomes
Negativity of blood culture results
Time frame: 48 hours and 96 hours after catheter replacement
Reduction of C-reactive protein
Time frame: 48 hours and 96 hours after catheter replacement
Reduction of Procalcitonin
Time frame: 48 hours and 96 hours after catheter replacement
Reduction of IL-6
Time frame: 48 hours and 96 hours after catheter replacement
Reduction of white blood cell count
Time frame: 48 hours and 96 hours after catheter replacement
28-day survival
Time frame: 28 days
ICU-free days at day 28
Time frame: 28 days
Vasopressor-free days at day 28
Time frame: 28 days
Invasive mechanical ventilation-free days at day 28
Time frame: 28 days
Antibiotic-free days at day 28
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin in people with Central Line-associated Bloodstream Infection (CLABSI) and Catheter-related Bloodstream Infection, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of infection (time frame: 96 hours after catheter replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.