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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to 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

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus (NCT05117398) is a Phase 3 interventional studying Catheter Bacteremia and Staphylococcus Aureus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. Cost-utility analyses; 7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Catheter Bacteremia, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 406 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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; - willing to sign a consent form form date and signed by the patient. Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Dalbavancin administration

A single-dose of intraveneuse (IV) administration of dalbavancin of 1500 mg. In case of patients with chronic renal impairment (creatinin clairance \< 30mL/min), a single-dose of IV administration of reduced dalbavancin of 1000 mg.

DRUG

Standard antibiotic therapy

Standard Antibiotic therapy according to national recommendations. During the study, the start of treatment is considered to be the day of inclusion/randomization (even if active antiobiotic treatment was started, less than 72 hours ago according to inclusion criteria).

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Infectious Diseases Department, Raymond-Poincaré Hospital - APHP
Garches, France
Infectious Diseases Department, CH PERIGUEUX
Périgueux, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05117398), the sponsor (Assistance Publique - Hôpitaux de Paris), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05117398 clinical trial studying?

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. C… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05117398?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05117398?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05117398. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05117398. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.