Prosthesis-related InfectionsDALBASATNCT06089044
Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
An observational study of Prosthesis-related Infections, run by Tourcoing Hospital at 1 site in France.
Trial summary
The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are: What is the proportion of patients with early discontinuation of dalbavancin therapy? What… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis-related Infections
- What is being tested?
- Dalbavancin Injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients hospitalized for a prosthetic device infection requiring suppressive antibiotic therapy for more than 6 months.
Who may be able to join
- Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
- Patients requiring suppressive antibiotic therapy (>6 months) with dalbavancin.
Who cannot join
- Patients who are protected adult;
- Patients who are minors;
- Patients having expressed their opposition
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:
What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Prosthesis-related Infections
- Being tested
- Dalbavancin Injection
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalbavancin InjectionDrug
Dalbavancin as long-term suppressive therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of suppressive Dalbavancin therapy
Proportion of patients successfully treated with Dalbavancin. The efficacy of suppressive therapy will be defined over a two-year period after initiation of treatment as the combination of the following criteria:
Clinical control of infection :
- Absence of local inflammatory signs (erythema, discharge, edema, pain) ;
- Absence of general signs (hyperthermia: T°>38 or hypothermia T°< 36°);
Biological control:
- CRP negative (<5mg/l) ;
Measured: two-year follow-up after initiation of suppressive therapy with Dalbavancin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis-related InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tourcoing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089044
- Sponsor's protocol ID
- CHT/URC/2023/12
- Acronym
- DALBASAT
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
- ClinicalTrials.gov ID
- NCT06089044
- Acronym / sponsor ID
- DALBASAT / CHT/URC/2023/12
- Conditions
- Prosthesis-related Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tourcoing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Oct 2023 (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 aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:
What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.
Translated with www.DeepL.com/Translator (free version)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for a prosthetic device infection requiring suppressive antibiotic therapy for more than 6 months.
Key inclusion criteria (2 listed)
- Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
- Patients requiring suppressive antibiotic therapy (>6 months) with dalbavancin.
Key exclusion criteria (3 listed)
- Patients who are protected adult;
- Patients who are minors;
- Patients having expressed their opposition
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 InjectionDalbavancin as long-term suppressive therapy. | Drug | – |
Primary outcome
efficacy of suppressive Dalbavancin therapy
Time frame: two-year follow-up after initiation of suppressive therapy with Dalbavancin
Proportion of patients successfully treated with Dalbavancin. The efficacy of suppressive therapy will be defined over a two-year period after initiation of treatment as the combination of the following criteria: Clinical control of infection : * Absence of local inflammatory signs (erythema, discharge, edema, pain) ; * Absence of general signs (hyperthermia: T°>38 or hypothermia T°< 36°); Biological control: o CRP negative (<5mg/l) ;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis-related Infections, run by Tourcoing Hospital at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of suppressive Dalbavancin therapy (time frame: two-year follow-up after initiation of suppressive therapy with Dalbavancin). 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 18 Oct 2023.