Catheter related bloodstream infections due to Staphylococcus aureus
Conditions
Brief summary
Clinical cure without relapse at Day 30, defined by the absence of all the following: Local and/or general signs of infection, Relapse of bacteremia to S. aureus ; In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14 In both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30, Deep focus infection including endocarditis, Death from all causes
Detailed description
Clinical cure at DAY 14 and DAY 90 (EOS), Death all-cause occurring within 90 days of follow-up, Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14, Autonomy, pain and anxiety using EQ-5D-5L scale at baseline (Day 0), DAY 14, DAY 30 and DAY 90 (EOS), Hospitalization duration in days, Cost per avoided relapse, life-year gained, and per quality-adjusted life year (QALY), Proportion of patients with any adverse event until EOS. It includes the complications due to venous catheterization
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure without relapse at Day 30, defined by the absence of all the following: Local and/or general signs of infection, Relapse of bacteremia to S. aureus ; In dalbavancin arm: Any additional antibiotic therapy active on S. aureus received between DAY 0 and DAY 14 In both arms: Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30, Deep focus infection including endocarditis, Death from all causes | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical cure at DAY 14 and DAY 90 (EOS), Death all-cause occurring within 90 days of follow-up, Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14, Autonomy, pain and anxiety using EQ-5D-5L scale at baseline (Day 0), DAY 14, DAY 30 and DAY 90 (EOS), Hospitalization duration in days, Cost per avoided relapse, life-year gained, and per quality-adjusted life year (QALY), Proportion of patients with any adverse event until EOS. It includes the complications due to venous catheterization | — |
Countries
France