Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial
Introduction Prosthetic joint infections (PJIs) are disastrous complications for patients and costly for healthcare organisations. They may promote bacterial resistance due to the extensive antibiotic use necessary in the PJI treatment. The PJI incidence is estimated to be 1%–3%, but the absolute nu...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e058168.full |
| _version_ | 1811182430405525504 |
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| author | Ola Rolfson Jonatan A N Tillander Karin Rilby Karin Svensson Malchau Susann Skovbjerg Erika Lindberg Margarita Trobos |
| author_facet | Ola Rolfson Jonatan A N Tillander Karin Rilby Karin Svensson Malchau Susann Skovbjerg Erika Lindberg Margarita Trobos |
| author_sort | Ola Rolfson |
| collection | DOAJ |
| description | Introduction Prosthetic joint infections (PJIs) are disastrous complications for patients and costly for healthcare organisations. They may promote bacterial resistance due to the extensive antibiotic use necessary in the PJI treatment. The PJI incidence is estimated to be 1%–3%, but the absolute numbers worldwide are high and increasing as large joint arthroplasties are performed by the millions each year. Current treatment algorithms, based on implant preserving surgery or full revision followed by a semitailored antibiotic regimen for no less than 2–3 months, lead to infection resolution in approximately 60% and 90%, respectively. Antibiotic choice is currently guided by minimum inhibitory concentrations (MICs) of free-living bacteria and not of bacteria in biofilm growth mode. Biofilm assays with relatively rapid output for the determination of minimum biofilm eradication concentrations (MBECs) have previously been developed but their clinical usefulness have not been established.Methods and analysis This single-blinded, two-arm randomised study of hip or knee staphylococcal PJI will evaluate 6-week standard of care (MIC guided), or an alternative antibiotic regimen according to an MBEC-guided-based decision algorithm. Sixty-four patients with a first-time PJI treated according to the debridement, antibiotics, and implant retention principle will be enrolled at a single tertiary orthopaedic centre (Sahlgrenska University Hospital). Patients will receive 14 days of standard parenteral antibiotics before entering the comparative study arms. The primary outcome measurement is the proportion of changes in antimicrobial regimen from first-line treatment dependent on randomisation arm. Secondary endpoints are unresolved infection, how microbial properties including biofilm abilities and emerging antimicrobial resistance correlate to infection outcomes, patient reported outcomes and costs with a 12-month follow-up.Ethics and dissemination Approval is received from the Swedish Ethical Review Authority, no 2020-01471 and the Swedish Medical Products Agency, EudraCT, no 2020-003444-80.Trial registration number ClinicalTrials.gov ID: NCT04488458. |
| first_indexed | 2024-04-11T09:31:15Z |
| format | Article |
| id | doaj.art-6a0e7129c9c046c3a710153ad9e0fed9 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T09:31:15Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-6a0e7129c9c046c3a710153ad9e0fed92022-12-22T04:31:52ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2021-058168Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trialOla Rolfson0Jonatan A N Tillander1Karin Rilby2Karin Svensson Malchau3Susann Skovbjerg4Erika Lindberg5Margarita Trobos6Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska University Hospital, Goteborg, SwedenDepartment of Infectious Diseases, Sahlgrenska University Hospital, Goteborg, SwedenDepartment of Orthopaedics, Sahlgrenska University Hospital, Goteborg, SwedenDepartment of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska University Hospital, Goteborg, SwedenDepartment of Clinical Microbiology, Institute of Biomedicine, University of Gothenburg, Goteborg, SwedenDepartment of Clinical Microbiology, Institute of Biomedicine, University of Gothenburg, Goteborg, SwedenDepartment of Biomaterials, University of Gothenburg Sahlgrenska Academy, Goteborg, SwedenIntroduction Prosthetic joint infections (PJIs) are disastrous complications for patients and costly for healthcare organisations. They may promote bacterial resistance due to the extensive antibiotic use necessary in the PJI treatment. The PJI incidence is estimated to be 1%–3%, but the absolute numbers worldwide are high and increasing as large joint arthroplasties are performed by the millions each year. Current treatment algorithms, based on implant preserving surgery or full revision followed by a semitailored antibiotic regimen for no less than 2–3 months, lead to infection resolution in approximately 60% and 90%, respectively. Antibiotic choice is currently guided by minimum inhibitory concentrations (MICs) of free-living bacteria and not of bacteria in biofilm growth mode. Biofilm assays with relatively rapid output for the determination of minimum biofilm eradication concentrations (MBECs) have previously been developed but their clinical usefulness have not been established.Methods and analysis This single-blinded, two-arm randomised study of hip or knee staphylococcal PJI will evaluate 6-week standard of care (MIC guided), or an alternative antibiotic regimen according to an MBEC-guided-based decision algorithm. Sixty-four patients with a first-time PJI treated according to the debridement, antibiotics, and implant retention principle will be enrolled at a single tertiary orthopaedic centre (Sahlgrenska University Hospital). Patients will receive 14 days of standard parenteral antibiotics before entering the comparative study arms. The primary outcome measurement is the proportion of changes in antimicrobial regimen from first-line treatment dependent on randomisation arm. Secondary endpoints are unresolved infection, how microbial properties including biofilm abilities and emerging antimicrobial resistance correlate to infection outcomes, patient reported outcomes and costs with a 12-month follow-up.Ethics and dissemination Approval is received from the Swedish Ethical Review Authority, no 2020-01471 and the Swedish Medical Products Agency, EudraCT, no 2020-003444-80.Trial registration number ClinicalTrials.gov ID: NCT04488458.https://bmjopen.bmj.com/content/12/9/e058168.full |
| spellingShingle | Ola Rolfson Jonatan A N Tillander Karin Rilby Karin Svensson Malchau Susann Skovbjerg Erika Lindberg Margarita Trobos Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial BMJ Open |
| title | Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial |
| title_full | Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial |
| title_fullStr | Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial |
| title_full_unstemmed | Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial |
| title_short | Treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration (MBEC) in addition to minimum inhibitory concentration (MIC): protocol for a prospective randomised clinical trial |
| title_sort | treatment of periprosthetic joint infections guided by minimum biofilm eradication concentration mbec in addition to minimum inhibitory concentration mic protocol for a prospective randomised clinical trial |
| url | https://bmjopen.bmj.com/content/12/9/e058168.full |
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