Side Effects of Antibiotics in Bone and Joint Infections

Recruiting

• Conditions: Bone Infection; Joint Infection

• Registration Number: NCT05927311
• Lead Sponsor: University Hospital, Tours

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.

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 Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-07-03
• Study Start: 2023-08-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-02
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient over 18 years of age
• Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
• Oral antibiotic therapy (minimum 4 weeks)

Exclusion Criteria

• Opposition to data processing
• Patient under guardianship or trusteeship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Tours, France