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Recruiting Observational

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

NCT05202964 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-06-13
Last updated
2026-10-13

Condition(s) studied

Drug-Related Side Effects and Adverse ReactionsTreatment Adherence and Compliance

Investigational drug(s) / intervention(s)

Tolerance and adherence to oral antibiotics in patients managed for BJI

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Hospices Civils de Lyon Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05202964 on ClinicalTrials.gov ↗ ← All trials in France