Side Effects of Antibiotics in Bone and Joint Infections (PROSEAB)

Prospective Study : Side Effects of Antibiotics in Bone and Joint Infections

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.

Study Overview

• Status: Completed
• Conditions: Bone Infection; Joint Infection

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient over 18 years of age with an osteoarticular infection requiring antibiotherapy of 6 weeks or more

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.	Day 15
Adverse reactions	Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.	Day 45
Adverse reactions	Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure	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.	Day 15, day 45, day 90
compliance of treatment	Analysis of compliance and discontinuation of treatment, taking into account the adverse reaction profile.	Day 15, day 45, day 90
Drug interactions	Analysis of drug interactions between antibiotic therapy for BJI and the patient's usual treatments at initiation and at each follow-up consultation.	Day 15, day 45, day 90
EQ5D-5L	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.	Day 365

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Marion LACASSE, CHRU de Tours

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2023
• Primary Completion (Actual): August 7, 2024
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: adverse events; antibiotherapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Disease Attributes; Arthritis; Joint Diseases; Infections; Communicable Diseases; Arthritis, Infectious
• Other Study ID Numbers: DR230121-PROSEAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No