NCT05202964

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

Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Tolerance and adherence to oral antibiotics in patients managed for BJI	Adherence will be measured 6 weeks (S6) and 3 months (M3) after the surgery. Tolerance will be mesured at baseline, and at 6 weeks (S6) and 3 months (M3) after the surgery. The compliance data collected will be compared by two methods (electronic pill dispensers and questionnaire). Patients will respond to a questionnaire about the tolerance of intraveinous antibiotics (between surgery and baseline) and oral antibiotics at baseline, and during the consultation at S6 and M3. Responses to the compliance questionnaire will be collected during a telephone interview by a member of the Croix-Rousse pharmacy at S6 and M3. The pill organizer data from S6 and M3 will be transferred to the software by a nurse.

Timeline

• Start date: 2024-06-13
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-01-24
• Last updated: 2025-02-13

Locations

1 site across 1 country: France