Side Effects of Antibiotics in Bone and Joint Infections

Joint Infection Clinical Trial

— PROSEAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927311
• Other study ID #: DR230121-PROSEAB
• Status: Recruiting
• Start date: August 11, 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Tours
• Contact: Marion LACASSE
• Phone: 0247476028
• Email: m.lacasse[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone Infection
• Communicable Diseases
• Infections
• Joint Infection

Locations

Country	Name	City	State
France	University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	compliance of treatment	Analysis of compliance and discontinuation of treatment, taking into account the adverse reaction profile.	Day 15, day 45, day 90
Secondary	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
Secondary	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