Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)

Recruiting

• Conditions: Treatment Adherence and Compliance; Drug-Related Side Effects and Adverse Reactions

• Registration Number: NCT05202964
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2024-06-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ≥ 18 years
• Diagnosis of osteoarticular infection
• Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date
• Patient who was informed and did not object to participate in the study

Exclusion Criteria

• Treatment for BJI with oral antibiotic without end of treatment date
• treatment for BJI with parenteral antibiotic only
• patient who doesn't have a telephone number or who doesn't want to give it
• Adults subject to a legal protection measure
• Pregnant or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of doses taken at 6 weeks	At 6 weeks after surgery	Ratio of the number of doses taken over the theoretical number of doses to be taken over the period
Percentage of doses taken at 3 months	at 3 months after surgery	Ratio of the number of doses taken over the theoretical number of doses to be taken over the period

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France