Clinical trial • Phase IV • Infectious Disease|Musculoskeletal
DALBAVANCIN for Periprosthetic joint infection
Phase IV trial of DALBAVANCIN for Periprosthetic joint infection.
Overview
- Trial Therapeutic Area
- Infectious Disease|Musculoskeletal
- Trial Disease
- Periprosthetic joint infection
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 05-07-2025
- First CTIS Authorization Date
- 02-10-2025
Trial design
Randomised, open-label, standard antibiotic therapy (comparator arms): one of multiple antibiotics chosen according to standard care, including clindamycin; amoxicillin; vancomycin; flucloxacillin; moxifloxacin; linezolid; rifampicin; dicloxacillin; fusidic acid; sulfamethoxazole + trimethoprim; levofloxacin; benzylpenicillin; cloxacillin. specific dosing regimens depend on clinical judgement; study indicates treatment periods of 6 or 12 weeks.-controlled Phase IV trial in Denmark.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard antibiotic therapy (comparator arms): one of multiple antibiotics chosen according to standard care, including Clindamycin; Amoxicillin; Vancomycin; Flucloxacillin; Moxifloxacin; Linezolid; Rifampicin; Dicloxacillin; Fusidic acid; Sulfamethoxazole + Trimethoprim; Levofloxacin; Benzylpenicillin; Cloxacillin. Specific dosing regimens depend on clinical judgement; study indicates treatment periods of 6 or 12 weeks.
- Target Sample Size
- 50
- Trial Duration For Participant
- 365
Eligibility
Recruits 50 No vulnerable populations selected; participants are adults (Age 18 years or older) and must provide "Signed consent forms." Separate subject information sheets and informed consent forms are provided for Group 1/2 and Group 3..
- Pregnancy Exclusion
- Pregnancy.
- Vulnerable Population
- No vulnerable populations selected; participants are adults (Age 18 years or older) and must provide "Signed consent forms." Separate subject information sheets and informed consent forms are provided for Group 1/2 and Group 3.
Inclusion criteria
- {"criterion_text":"- Signed consent forms.\n- Age 18 years or older.\n- 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.\n- Group 3: Participants scheduled for elective knee replacement surgery at the Department of Orthopaedic Surgery, Aarhus University Hospital."}
Exclusion criteria
- {"criterion_text":"- Allergy to gentamicin, ceftriaxone or glycopeptides (dalbavancin, vancomycin, teicoplanin).\n- Periprosthetic joint infection in knee, hip, or shoulder caused by a gram-negative bacteria.\n- Impaired renal function with eGFR<30.\n- Pregnancy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cost-utility analysis during antibiotic treatment (intention-to-treat): Absolute treatment costs during the acute treatment period of 6 or 12 weeks of antibiotics in the two treatment groups, assessed in relation to quality-adjusted life years (QALYs).","definition_or_measurement_approach":"Absolute treatment costs during the acute treatment period of 6 or 12 weeks in the two treatment groups, assessed in relation to quality-adjusted life years (QALYs) (cost-utility analysis, intention-to-treat)."}
Secondary endpoints
- {"endpoint_text":"- Cost-utility analysis after one-year of follow-up (per protocol): Long-term health economics and patient-experienced quality of life, incorporating long-term effects and any late complications or recurrence within the first year.","definition_or_measurement_approach":"Long-term health economics and patient-experienced quality of life at one year (per protocol), incorporating late complications or recurrence within the first year."}
- {"endpoint_text":"- Physical activity: Average daily activity during the treatment period (6 or 12 weeks), recorded using an activity tracker.","definition_or_measurement_approach":"Average daily activity recorded with an activity tracker during the antibiotic treatment period (6 or 12 weeks)."}
- {"endpoint_text":"- Tissue concentration: Standard pharmacokinetic parameters (e.g., AUC/MIC, T>MIC, AUC, T½, Cmax, Tmax) in bone tissue, subcutaneous tissue, and plasma.","definition_or_measurement_approach":"Measurement of PK parameters (AUC/MIC, T>MIC, AUC, T½, Cmax, Tmax) in bone, subcutaneous tissue and plasma (microdialysis subgroup and plasma sampling)."}
- {"endpoint_text":"- Gut response: Gut microbiome diversity profile and resistome, including AMR genes.","definition_or_measurement_approach":"Sequencing-based assessment of gut microbiome diversity and resistome, including AMR gene profiling and bioinformatic analyses comparing treatment arms."}
- {"endpoint_text":"- Immune response: Standard histological examination of HE stains with quantification of the infiltration of neutrophil granulocytes, macrophages, and lymphocytes. In addition, histological identification of specific genes and proteins involved in inflammatory and immune-regulatory pathways.","definition_or_measurement_approach":"Histological and molecular analyses of surgical tissue samples: HE staining quantification of immune cell infiltration and identification/quantification of genes/proteins in inflammatory and immune-regulatory pathways."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 27
- Consent Approach
- Participants (aged 18 years or older) must provide signed informed consent. Separate subject information sheets and informed consent forms are provided for Group 1/2 and Group 3 (documents L1, L3, L5). Patient-facing documents are labelled _DA indicating Danish-language materials.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 66
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Region Midtjylland (Palle Juul-Jensens Boulevard 99, Aarhus N)
- Department Name
- Orthopaedic Surgery
- Principal Investigator Name
- Mats Bue
- Principal Investigator Email
- mats.bue@rm.dk
- Contact Person Name
- Mats Bue
- Contact Person Email
- mats.bue@rm.dk
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Department of Veterinary and Animal Sciences","duties_or_roles":"code 4","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"code 1","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"Department of Plant and Environmental Sciences","duties_or_roles":"code 4","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"Department of Public Health","duties_or_roles":"code 6","organisation_type":"Educational Institution"}
Co-sponsors
- Aarhus Universitet
Investigational products
- Investigational Product Name
- DALBAVANCIN
- Active Substance
- DALBAVANCIN
- Modality
- Other
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Starting Dose
- 1500 mg IV over 30 minutes (single dose for Group 3). Treatment dosing for Groups 1B/2B not specified in available text.
- Frequency
- Single dose (Group 3); treatment schedule for infected groups not specified
- Maximum Dose
- 1.5 g (max daily dose amount in record)
- Investigational Product Name
- VANCOMYCIN
- Active Substance
- VANCOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Maximum Dose
- 60 mg/Kg (max daily dose amount recorded)
- Investigational Product Name
- AMOXICILLIN
- Active Substance
- AMOXICILLIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Maximum Dose
- 4 g per day (max daily dose amount recorded)
- Investigational Product Name
- CLINDAMYCIN
- Active Substance
- CLINDAMYCIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 1.8 g per day (max daily dose amount recorded)
- Investigational Product Name
- FLUCLOXACILLIN
- Active Substance
- FLUCLOXACILLIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 4 g per day (max daily dose amount recorded)
- Investigational Product Name
- MOXIFLOXACIN
- Active Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 0.4 g per day (max daily dose amount recorded)
- Investigational Product Name
- LINEZOLID
- Active Substance
- LINEZOLID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 1.2 g per day (max daily dose amount recorded)
- Investigational Product Name
- RIFAMPICIN
- Active Substance
- RIFAMPICIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 0.9 g per day (max daily dose amount recorded)
- Investigational Product Name
- LEVOFLOXACIN
- Active Substance
- LEVOFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 1 g per day (max daily dose amount recorded)
- Investigational Product Name
- CEFTRIAXONE
- Active Substance
- CEFTRIAXONE SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Maximum Dose
- 4 g per day (max daily dose amount recorded)
- Investigational Product Name
- GENTAMICIN (topical/combined preparation record)
- Active Substance
- BETAMETHASONE VALERATE, GENTAMICIN SULFATE
- Modality
- Small molecule
- Routes Of Administration
- LOCAL USE
- Route
- Local
- Maximum Dose
- 650 mg (max daily dose amount recorded)
- Investigational Product Name
- FUSIDIC ACID
- Active Substance
- FUSIDIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 1.5 g per day (max daily dose amount recorded)
- Investigational Product Name
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Active Substance
- BROMHEXINE HYDROCHLORIDE, SULFAMETHOXAZOLE, TRIMETHOPRIM
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 2.88 g per day (max daily dose amount recorded)
- Investigational Product Name
- BENZYLPENICILLIN (procaine/benzathine/potassium formulations)
- Active Substance
- BENZYLPENICILLIN PROCAINE, BENZATHINE BENZYLPENICILLIN, BENZYLPENICILLIN POTASSIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Maximum Dose
- 4.8 g per day (max daily dose amount recorded)
- Investigational Product Name
- CLOXACILLIN
- Active Substance
- CLOXACILLIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS ADMINISTRATION
- Route
- Intravenous
- Maximum Dose
- 8 g per day (max daily dose amount recorded)
- Investigational Product Name
- DICLOXACILLIN
- Active Substance
- DICLOXACILLIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Maximum Dose
- 4 g per day (max daily dose amount recorded)
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