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The DALBA-study Introduction of the antibiotic dalbavancin in orthopaedic surgery – an evaluation of: • Health economic costs • Patient-reported outcomes on quality of life • Local bone and soft tissue concentrations • Effect on the gut microbiome A randomised controlled study of dalbavancin versus standard antibiotic treatment of Gram-positive periprosthetic joint infections.
EU CTIS ID: 2025-522088-13-00
What this study is testing
To perform a cost-utility analysis (CUA) in a randomized clinical trial including patients with knee, hip, or shoulder periprosthetic joint infections. Participants are randomized to receive either standard antibiotic therapy or dalbavancin. Health economic costs will be compared between the two treatment groups and assessed in relation to patients’ health-related quality of life. Economic data will be collected from Aarhus University Hospital and Statistics Denmark. Quality of life will be measured using patient-reported outcome measures (PROMs).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed consent forms.
- Age 18 years or older.
- Groups 1+2: Participants with suspected gram-positive PJI in the knee, hip, or shoulder requiring revision with either DAIR or one-stage surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital.
- Group 3: Participants scheduled for elective knee replacement surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital.
You likely can't join if
- Allergy to gentamicin, ceftriaxone or glycopeptides (dalbavancin, vancomycin, teicoplanin).
- Periprosthetic joint infection in knee, hip, or shoulder caused by a gram-negative bacteria.
- Impaired renal function with eGFR<30.
- Pregnancy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.