A Phase 3 interventional study of Dalbavancin administration and Standard antibiotic therapy in Catheter Bacteremia and Staphylococcus Aureus Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Among 64 studies in Staphylococcal Infections with a site in France — 12 open to participants now, 13 under way, 2 of them phase 3. Staphylococcal Infections · France.
Among the 64 studies in Staphylococcal Infections with a site in France, this one is the 6th largest by planned enrollment of the 31 interventional ones, is one of 3 that started in 2023, is one of 5 in phase 3, reaches primary completion later than 3 of the 12 other live ones, and was the 50th registered.
303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.
This study's planned enrollment of 406 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.
Browse Staphylococcal Infections studies →12 of the 64 studies in Staphylococcal Infections with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 22 Staphylococcal Infections studies recruiting now, 16 (73%) set no upper age limit and 4 (18%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →64 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2023.
Median enrollment 121 across the 31 interventional studies, 102 across the 33 observational. Of the 44 that completed or were terminated, 4 (9%) have results posted.
9 of 64 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 7 studies filed under Staphylococcal Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Staphylococcal Infections with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06124599Hospices Civils de LyonProdromes of Menstrual Staphylococcal Toxic Shock | 2026-12-21 |
Among the 64 studies in Staphylococcal Infections with a site in France, from their registry updates:
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:
Catheter-related bloodstream infections (CR-BSIs) are the most common nosocomial bloodstream infections, with an incidence as high as 8.5 to 19.8 infections per 1000 catheter-days. Staphylococcus aureus is involved in about 20% of CR-BSIs and associated with significant morbidity, mortality (9.3%), prolonged hospital stay (+ 9 days), and healthcare costs (35 000 € to 65 000 € per case). S. aureus CR-BSIs occurs mainly in frail patients with a port of catheter for chemotherapy or parenteral nutrition.
According to international guidelines, management of CR-BSIs due to S. aureus includes the removal and replacement of the infected catheter and a 14-day intravenous (IV) antibiotic therapy. Therefore, the management of CR-BSIs due to S. aureus requires the insertion of a new intravenous catheter. In turn, the new catheter can also lead to new septic complications and limit the patients' autonomy. Non-adherence to these recommendations leads to over-mortality and costs.
Following of the positive results of the SABATO trial in 2021 to determine whether early switch to oral antibiotic therapy is safe and effective in patients with uncomplicated BSA, oral switch during staphylococcal bacteremia, will likely become the standard of care. It is therefore justified to allow oral switch in the control arm.
The usual practice in some centers is already to switch to oral antibiotics, after a minimum of 7 days of intravenous treatment.
Dalbavancin is a new glycopeptide antibiotic, with an excellent bactericidal activity against Gram-positive bacteria, especially S. aureus, and a prolonged half-life of 14 to 15 days. As a comparison, half-life of antibiotics usually used for CR-BSIs due to S. aureus, i.e. penicillin or glycopeptide, as-per sensitivity to methicillin is much lower: 1.5 to 9 hours. Such prolonged half-life allows one IV injection to be sufficient and effective over 14 days of treatment. This remarkable characteristic should allow patients to be promptly discharged from hospital without monitoring.
The hypothesis of the study is that in patients with CR-BSIs due to S. aureus, after catheter removal, dalbavancin could be administered intravenously in a single administration after catheter removal and be as effective as standard documented antibiotic therapy for 14 days according to national guidelines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CR-BSI, defined as:
Exclusion Criteria:
Severely patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dalbavancin (Xydalba®) 1500 mg - One unique dose
Drug: Dalbavancin administration
As currently recommended, investigators will be encouraged to use the intravenous route for the entire duration of treatment. However, in order to interfere as little as possible with usual practice in each center, the antimicrobial therapy will be let to the choice of the physician in charge of the patient after a minimum of 7 days of intravenous treatment. During all the duration of the study, in case of worsening of the clinical condition requiring the prescription of antistaphylococcal, the clinician will prescribe additional antibiotherapy according to standard good practice.
Drug: Standard antibiotic therapy
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.
Also known as: Xydalba® administration
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).
Also known as: Standard documented antibiotic therapy
Cure rate
Clinical cure without relapse, defined by the absence of all the following: * Local and/or general signs of infection: * Relapse of bacteremia to S. aureus - i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials); * 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.
Time frame: DAY 30
Cure rate
Clinical cure at DAY 14 and DAY 90 (EOS) defined by the absence of all the following: * For DAY 14 and DAY 90: a. Local and/or general signs of infection: i. local: redness, induration, swelling, purulent discharge; ii. general: fever, chills; b. Relapse of bacteremia to S. aureus - i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials); * Additional criteria at EOS only: c. Any additional antibiotic therapy active on S. aureus received between DAY 14 and DAY 90 (EOS);
Time frame: DAY 14;DAY 90 (EOS)
Mortality rate
Death all-cause occurring within 90 days of follow-up.
Time frame: DAY 90
Bloodstream clearance
Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14.
Time frame: DAY 14
Patient's quality of life
Autonomy, pain and anxiety using 5-level EQ-5D scale
Time frame: BASELINE; DAY 14; DAY 30; DAY 90 (EOS)
Hospitalization length of stay
Hospitalization duration in days
Time frame: DAY 90
Cost-utility analyses
Cost per avoided relapse; life-year gained, and per quality-adjusted life year (QALY)
Time frame: DAY 90
Incidence of any adverse event (AE and SAE)
Proportion of patients with any adverse event until the end of study. It includes the complications due to venous catheterization.
Time frame: DAY 90
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Sep 2025, 27 months after the start.
How these figures are worked out, and which studies are left out of them.
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