Comparing dalbavancin to standard antibiotics for bloodstream infections from Staphylococcus aureus

Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

This study is testing if a single dose of dalbavancin works as well as standard antibiotics for treating bloodstream infections caused by Staphylococcus aureus in patients who have had their infected catheters removed.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Garches and 1 other locations)
• Trial ID: NCT05117398 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a single dose of intravenous dalbavancin compared to standard antibiotic therapy for treating catheter-related bloodstream infections (CR-BSIs) caused by Staphylococcus aureus. The primary objective is to demonstrate that dalbavancin is non-inferior to the standard treatment over a 30-day follow-up period. Secondary objectives include assessing cure rates, mortality rates, time to negative blood cultures, quality of life, length of hospital stay, cost-utility, and adverse events. The study targets patients with uncomplicated CR-BSIs who have had their infected catheters removed prior to randomization.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed Staphylococcus aureus CR-BSIs who have had their infected catheters removed.

Not a fit: Patients with polymicrobial infections or those who do not meet the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and convenient treatment option for patients suffering from catheter-related bloodstream infections.

How similar studies have performed: Previous studies, such as the SABATO trial, have shown promising results for similar approaches, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Patients aged at least 18 years;
* Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);
* CR-BSI, defined as:

  * One positive blood culture AND Local signs of infection at the catheter site; OR
  * at least one positive blood culture obtained from the catheter and the peripheral vein; AND
  * A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND
  * Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures; OR
  * One positive blood culture; AND
  * Strong presumption of catheter-related infection according to clinical opinion.
* Intravascular catheter - implantable venous access device (port-a-cath and Piccline) - removed before randomization;
* Informed consent form date and signed by the patient.

Exclusion Criteria:

* Polymicrobial infection;
* Dalbavancin resistant strain;
* More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;
* Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;
* Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);
* Thrombophlebitis;
* Failure to remove any intravascular catheter which was present when first positive blood culture;
* Signs of infection associated with quick SOFA score ≥ 2 at randomization;
* Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device;
* Severe liver disease (Child-Pugh C);
* Severely immunocompromised patients:

  * Neutropenia (\< 500 neutrophils/µL) at randomization;
  * Hematopoietic stem cell transplantation within the past 6 months or planned during treatment period;
  * Solid organ transplant;
* Contraindication to dalbavancin and/or glycopeptide;
* Life expectancy \< 3 months;
* Active injection drug user;
* Pregnant or breastfeeding women;
* For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug;
* Participation in other interventional trials ongoing;
* Persons held in an institution by legal or official order;
* Patients under legal protection;
* Patients under guardianship or curators;
* Patients unable to give a free and informed consent;
* Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.

Where this trial is running

Garches and 1 other locations

• Infectious Diseases Department, Raymond-Poincaré Hospital - APHP — Garches, France (Not_yet_recruiting)
• Infectious Diseases Department, CH PERIGUEUX — Périgueux, France (Recruiting)

Study contacts

• Principal investigator: Bernard CASTAN, MD — CH de Perigueux
• Study coordinator: Bernard CASTAN, MD

Conditions Catheter Bacteremia; Staphylococcus Aureus Infection; catheter-related bloodstream infections; Staphylococcus aureus infection