Clinical trial • Phase II • Infectious Disease|Musculoskeletal
Vancomycin for Prosthetic joint infection
Phase II trial of Vancomycin for Prosthetic joint infection.
Overview
- Trial Therapeutic Area
- Infectious Disease|Musculoskeletal
- Trial Disease
- Prosthetic joint infection
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-03-2024
- First CTIS Authorization Date
- 19-03-2024
Trial design
Randomised, placebo impregnated bone graft: morselized bone graft impregnated with 8 ml nacl (placebo); antibiotic impregnated bone graft: 8 ml of tobramycin (80 mg/ml) aspirated and used to dissolve 1 g vancomycin powder, solution mixed with morselized bone graft (single intraoperative application).-controlled Phase II trial across 13 sites in Sweden.
- Randomised
- Yes
- Comparator
- Placebo impregnated bone graft: Morselized bone graft impregnated with 8 ml NaCl (placebo); Antibiotic impregnated bone graft: 8 ml of tobramycin (80 mg/ml) aspirated and used to dissolve 1 g vancomycin powder, solution mixed with morselized bone graft (single intraoperative application).
- Target Sample Size
- 1100
- Trial Duration For Participant
- 1825
Eligibility
Recruits 1100 Vulnerable populations are not selected (isVulnerablePopulationSelected=false). Participants must be adults (Age ≥ 18) and willing to provide informed consent. Mental inability, reluctance, or language difficulties that impair understanding are listed as exclusion criteria. No assent procedures or specific consent-by-proxy arrangements are described..
- Pregnancy Exclusion
- Pregnant females
- Vulnerable Population
- Vulnerable populations are not selected (isVulnerablePopulationSelected=false). Participants must be adults (Age ≥ 18) and willing to provide informed consent. Mental inability, reluctance, or language difficulties that impair understanding are listed as exclusion criteria. No assent procedures or specific consent-by-proxy arrangements are described.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years\n- Hip arthroplasty requiring bone graft\n- Willing to provide informed consent\n- For females of childbearing potential; a negative pregnancy test prior to reoperation"}
Exclusion criteria
- {"criterion_text":"- Ongoing prosthetic joint infection\n- Known allergies and contraindications for the use of vancomycin or tobramycin\n- Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation\n- Expected difficulties to complete 2-year follow-up\n- Females of child bearing potential not using contraception\n- Pregnant females\n- Nursing females"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty","definition_or_measurement_approach":"Event-based: occurrence of reoperation due to infection or diagnosed prosthetic joint infection (PJI) with bacteria sensitive to vancomycin or tobramycin in the operated hip within 2 years after hip arthroplasty."}
Secondary endpoints
- {"endpoint_text":"- Time and cause for reoperation for any reason within 2 and 5 years","definition_or_measurement_approach":"Time-to-event measurement: time from index surgery to reoperation and recorded cause, assessed at 2 and 5 years."}
- {"endpoint_text":"- Time and cause for implant revision due to any reason within 2 and 5 years","definition_or_measurement_approach":"Time-to-event measurement: time from index surgery to implant revision and recorded reason, assessed at 2 and 5 years."}
- {"endpoint_text":"- Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection","definition_or_measurement_approach":"Microbiological assessment of isolates from postoperative infections, with species identification and antibiotic susceptibility/resistance patterns."}
- {"endpoint_text":"- Differences between the two experimental groups regarding the frequencies of adverse events","definition_or_measurement_approach":"Frequency counts and comparative analysis of reported adverse events between groups."}
- {"endpoint_text":"- Differences between the two experimental groups regarding the rates of revision due to aseptic loosening","definition_or_measurement_approach":"Comparative assessment of rates of revision surgery attributed to aseptic loosening between groups over follow-up."}
Recruitment
- Planned Sample Size
- 1100
- Recruitment Window Months
- 109
- Consent Approach
- Informed consent required from participants; adults (≥18) provide consent. Consent documentation referenced (Subject information and informed consent form: L1-SIS and ICF_RCT and cohort). No details on assent or multiple-language documents provided in the record.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 1100
Sweden
- Earliest CTIS Part Ii Submission Date
- 17-01-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 803
- Number Of Sites
- 13
- Number Of Participants
- 1100
Sites
- Site Name
- Region Skane Hassleholm Hospital
- Department Name
- orthopedi
- Principal Investigator Name
- Muhanned ALI
- Principal Investigator Email
- muhanned.ali@skane.se
- Contact Person Name
- Muhanned ALI
- Contact Person Email
- muhanned.ali@skane.se
- Site Name
- Region Dalarna
- Department Name
- orthopedi
- Principal Investigator Name
- Johan Risberg
- Principal Investigator Email
- johan.risberg@regiondalarna.se
- Contact Person Name
- Johan Risberg
- Contact Person Email
- johan.risberg@regiondalarna.se
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- orthopedi
- Principal Investigator Name
- Georgios Tsikandylakis
- Principal Investigator Email
- georgios.tsikandylakis@vgregion.se
- Contact Person Name
- Georgios Tsikandylakis
- Contact Person Email
- georgios.tsikandylakis@vgregion.se
- Site Name
- Laenssjukhuset I Kalmar Region Kalmar Laen
- Department Name
- orthopedi
- Principal Investigator Name
- Rasmus Bjerre
- Principal Investigator Email
- rasmus.bjerre@regionkalmar.se
- Contact Person Name
- Rasmus Bjerre
- Contact Person Email
- rasmus.bjerre@regionkalmar.se
- Site Name
- Lasarettet I Motala Region Ostergotland
- Department Name
- orthopedi
- Principal Investigator Name
- Jonathan Brandt
- Principal Investigator Email
- jonathan.brandt@liu.se
- Contact Person Name
- Jonathan Brandt
- Contact Person Email
- jonathan.brandt@liu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- orthopedi
- Principal Investigator Name
- Anna Stefansdottir
- Principal Investigator Email
- Anna.Stefansdottir@skane.se
- Contact Person Name
- Anna Stefansdottir
- Contact Person Email
- Anna.Stefansdottir@skane.se
- Site Name
- Vaesterviks Sjukhus Region Kalmar Laen
- Department Name
- othopedi
- Principal Investigator Name
- Per Malmberg
- Principal Investigator Email
- Per.malmberg@regionkalmar.se
- Contact Person Name
- Per Malmberg
- Contact Person Email
- Per.malmberg@regionkalmar.se
- Site Name
- Danderyds Sjukhus AB
- Department Name
- orthopedi
- Principal Investigator Name
- Olof Sköldenberg
- Principal Investigator Email
- olof.skoldenberg@ki.se
- Contact Person Name
- Olof Sköldenberg
- Contact Person Email
- olof.skoldenberg@ki.se
- Site Name
- Region Oestergoetland
- Department Name
- Orthopedi
- Principal Investigator Name
- Jörg Schilcher
- Principal Investigator Email
- jorg.schilcher@liu.se
- Contact Person Name
- Jörg Schilcher
- Contact Person Email
- jorg.schilcher@liu.se
- Site Name
- Region Oerebro Laen
- Department Name
- orthopedi
- Principal Investigator Name
- Peter Wildeman
- Principal Investigator Email
- peter.wildeman@regionorebrolan.se
- Contact Person Name
- Peter Wildeman
- Contact Person Email
- peter.wildeman@regionorebrolan.se
- Site Name
- Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
- Department Name
- Orthopedi
- Principal Investigator Name
- Martin Gusmark
- Principal Investigator Email
- region@regionostergotland.se
- Contact Person Name
- Martin Gusmark
- Contact Person Email
- region@regionostergotland.se
- Site Name
- Uppsala University Hospital
- Department Name
- Orthopedi
- Principal Investigator Name
- Stergios Lazarinis
- Principal Investigator Email
- stergios.lazarinis@akademiska.se
- Contact Person Name
- Stergios Lazarinis
- Contact Person Email
- stergios.lazarinis@akademiska.se
- Site Name
- Region Skane Lasarettet Trelleborg
- Department Name
- Ortopedi
- Principal Investigator Name
- Anna Stefánsdóttir
- Principal Investigator Email
- Anna.Stefansdottir@skane.se
- Contact Person Name
- Anna Stefánsdóttir
- Contact Person Email
- Anna.Stefansdottir@skane.se
Sponsor
Primary sponsor
- Full Name
- Region Oestergoetland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- VANCOMYCIN
- Active Substance
- Vancomycin
- Modality
- Small molecule
- Routes Of Administration
- INTRAARTICULAR USE
- Route
- Intraarticular (impregnated bone graft applied during hip arthroplasty)
- Starting Dose
- 1 g (vancomycin powder dissolved into solution applied to morselized bone graft intraoperatively)
- Dose Levels
- Single intraoperative dose of 1 g mixed into graft
- Frequency
- Single intraoperative application
- Maximum Dose
- 3000 mg (maxTotalDoseAmount listed in product data)
- Investigational Product Name
- TOBRAMYCIN
- Active Substance
- Tobramycin sulfate
- Modality
- Small molecule
- Routes Of Administration
- INTRAARTICULAR USE
- Route
- Intraarticular (impregnated bone graft applied during hip arthroplasty)
- Starting Dose
- 8 ml of tobramycin (80 mg/ml) → 640 mg (aspirated and used to dissolve vancomycin powder, applied to morselized bone graft intraoperatively)
- Dose Levels
- Single intraoperative dose of 8 ml (80 mg/ml)
- Frequency
- Single intraoperative application
- Maximum Dose
- 1920 mg (maxTotalDoseAmount listed in product data)
- Investigational Product Name
- SALINE (placebo)
- Active Substance
- Saline
- Modality
- Other
- Routes Of Administration
- INTRAARTICULAR USE
- Route
- Intraarticular (impregnated bone graft applied during hip arthroplasty)
- Starting Dose
- 8 ml NaCl
- Dose Levels
- Single intraoperative dose of 8 ml NaCl used to impregnate morselized bone graft
- Frequency
- Single intraoperative application
- Maximum Dose
- 8 ml
- Combination Treatment
- Yes
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