PROSEAB: Side Effects of Antibiotics in Bone and Joint Infections
Study Details
Study Description
Brief Summary
Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
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Detailed Description
Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.
The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.
Study Design
Outcome Measures
Primary Outcome Measures
- Adverse reactions [Day 15]
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
- Adverse reactions [Day 45]
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
- Adverse reactions [Day 90]
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Secondary Outcome Measures
- Treatment failure [Day 15, day 45, day 90]
In the absence of the criterion of certainty, probable failure is defined by clinical (fever, pain, functional impotence, etc.), radiological (edging, signs of osteitis, etc.) and biological (increased CRP, hyperleukocytosis in the absence of any other cause) arguments.
- compliance of treatment [Day 15, day 45, day 90]
Analysis of compliance and discontinuation of treatment, taking into account the adverse reaction profile.
- Drug interactions [Day 15, day 45, day 90]
Analysis of drug interactions between antibiotic therapy for BJI and the patient's usual treatments at initiation and at each follow-up consultation.
- EQ5D-5L [Day 365]
Quality of life will be assessed using the EuroQol 5 dimensions-5 levels (EQ-5D-5L) score questionnaire at the end of follow-up. Each one of the 5 scales goes from 1 to 5, 1 being the best possible outcome while 5 being the worst.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient over 18 years of age
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Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
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Oral antibiotic therapy (minimum 4 weeks)
Exclusion Criteria:
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Opposition to data processing
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Patient under guardianship or trusteeship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | University Hospital | Tours | France | 37044 |
Sponsors and Collaborators
- University Hospital, Tours
Investigators
- Principal Investigator: Marion LACASSE, CHRU de Tours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DR230121-PROSEAB