Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
Conditions
Keywords
Tolerance, Adherence, Antibiotic, BJI, adverse effect
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.
Interventions
OTHERTolerance 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.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactTristan FERRY, MD, PHD
Outcome results
None listed