Catheter BacteremiaPhase 3DALICATHNCT05117398
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
A Phase 3 study testing Dalbavancin administration and Standard antibiotic therapy in people with Catheter Bacteremia and Staphylococcus Aureus Infection, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Bacteremia, Staphylococcus Aureus Infection
- What is being tested?
- Dalbavancin administration and Standard antibiotic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2023to 23 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Infectious Diseases Department, Raymond-Poincaré Hospital - APHP
Garches, 92380
Aurelien DIHN, MD, PhD
- Recruiting
Infectious Diseases Department, CH PERIGUEUX
Périgueux, 24019
Bernard CASTAN, MD
About this study
Official title: Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
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:
- Cure rate at DAY 14 and DAY 90 (EOS);
- Mortality rate within 90 days of follow-up;
- Time to negativation of blood cultures;
- Patient's quality of life;
- Hospitalization length of stay;
- Cost-utility analyses;
- Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).
Read the detailed description
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.
- Being tested
- Dalbavancin administration, Standard antibiotic therapy
- Keywords
- catheter-related bloodstream infections, Staphylococcus aureus infection
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalbavancin administrationDrug
Also called Xydalba® 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.
Standard antibiotic therapyDrug
Also called Standard documented 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).
| Study group | Role | What they receive |
|---|---|---|
| Dalbavancin | Experimental | Dalbavancin (Xydalba®) 1500 mg - One unique dose Receives: Drug: Dalbavancin administration |
| Standard documented antibiotic therapy for 14 days according to national guidelines. | Active comparator | 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. Receives: Drug: Standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: DAY 30
Secondary outcomes (7)
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:
- 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:
- Any additional antibiotic therapy active on S. aureus received between DAY 14 and DAY 90 (EOS);
Measured: DAY 14;DAY 90 (EOS)
Mortality rate
Death all-cause occurring within 90 days of follow-up.
Measured: DAY 90
Bloodstream clearance
Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14.
Measured: DAY 14
Patient's quality of life
Autonomy, pain and anxiety using 5-level EQ-5D scale
Measured: BASELINE; DAY 14; DAY 30; DAY 90 (EOS)
Hospitalization length of stay
Hospitalization duration in days
Measured: DAY 90
Cost-utility analyses
Cost per avoided relapse; life-year gained, and per quality-adjusted life year (QALY)
Measured: 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.
Measured: DAY 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start23 Jun 2023
- Primary completion23 Sep 2025 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter BacteremiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, pragmatic, open-label, non-inferiority, randomized (1:1), multicenter trial, in patients with non-complicated CR-BSI due to S. aureus, with two parallel groups receiving 14 days of active antimicrobial therapy.
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Perigueux, Advanz Pharma, Nantes University Hospital, Centre National de Référence des staphylocoques
- Responsible party
- Sponsor
- Investigators
- Bernard CASTAN, MD, Principal investigator, CH de PerigueuxAurélien DINH, MD, PhD, Study director, APHP - RAYMOND POINCARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117398
- Sponsor's protocol ID
- APHP220763
- Other IDs
- 2021-004038-12
- Acronym
- DALICATH
- Status last verified
- Mar 2025
- First submitted
- 21 Oct 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT05117398
- Acronym / sponsor ID
- DALICATH / APHP220763
- Keywords
- catheter-related bloodstream infections, Staphylococcus aureus infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Perigueux, Advanz Pharma, Nantes University Hospital, Centre National de Référence des staphylocoques
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Sep 2025 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Cure rate at DAY 14 and DAY 90 (EOS);
- Mortality rate within 90 days of follow-up;
- Time to negativation of blood cultures;
- Patient's quality of life;
- Hospitalization length of stay;
- Cost-utility analyses;
- Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III, pragmatic, open-label, non-inferiority, randomized (1:1), multicenter trial, in patients with non-complicated CR-BSI due to S. aureus, with two parallel groups receiving 14 days of active antimicrobial therapy.
| Arm | Type | Receives |
|---|---|---|
| Dalbavancin | Experimental | Drug: Dalbavancin administrationDalbavancin (Xydalba®) 1500 mg - One unique dose |
| Standard documented antibiotic therapy for 14 days according to national guidelines. | Active comparator | Drug: Standard antibiotic therapyAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Intravascular catheter - implantable venous access device (port-a-cath and Piccline) - removed before randomization;
- Informed consent form date and signed by the patient.
Key exclusion criteria (25 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalbavancin administrationAlso: Xydalba® administrationA 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 | Dalbavancin |
| Standard antibiotic therapyAlso: Standard documented antibiotic therapyStandard 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). | Drug | Standard documented antibiotic therapy for 14 days according to national guidelines. |
Primary outcome
Cure rate
Time frame: DAY 30
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.
7 secondary outcomes
Cure rate
Time frame: DAY 14;DAY 90 (EOS)
Mortality rate
Time frame: DAY 90
Bloodstream clearance
Time frame: DAY 14
Patient's quality of life
Time frame: BASELINE; DAY 14; DAY 30; DAY 90 (EOS)
Hospitalization length of stay
Time frame: DAY 90
Cost-utility analyses
Time frame: DAY 90
Incidence of any adverse event (AE and SAE)
Time frame: DAY 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Superficial Vein Thrombosis of the Upper Limb in Bacteremia Associated With PICCline and Midline Catheters: Frequency and Clinical Consequences
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernard CASTAN, MD principal investigator
CH de Perigueux
Aurélien DINH, MD, PhD study director
APHP - RAYMOND POINCARE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dalbavancin administration and Standard antibiotic therapy in people with Catheter Bacteremia and Staphylococcus Aureus Infection, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard CASTAN, MD (+33 5 53 45 26 00, bernard.castan@ch-perigueux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: DAY 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.