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Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheterrelated bloodstream infections due to Staphylococcus aureus [DALICATH]

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514952-34-00
Acronym
APHP220763
Enrollment
406
Registered
2024-09-12
Start date
2023-06-23
Completion date
Unknown
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter related bloodstream infections due to Staphylococcus aureus

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

DRUGTEICOPLANIN
DRUGCIPROFLOXACIN
DRUGTIGECYCLINE
DRUGCEFTRIAXONE
DRUGDOXYCYCLINE
DRUGAMIKACIN
DRUGCEFAZOLIN
DRUGAMOXICILLIN
DRUGLEVOFLOXACIN
DRUGDAPTOMYCIN
DRUGLINEZOLID
DRUGCLINDAMYCIN
DRUGRIFAMPICIN
DRUGVANCOMYCIN
DRUGCEFOTAXIME
DRUGGENTAMICIN

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026