Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tolerance and adherence to oral antibiotics in patients managed for BJI.
- Who it may be relevant to
- Registry conditions: Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections
Overview
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
- 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 c
Primary outcome measures
- Percentage of doses taken at 6 weeks [Time frame: At 6 weeks after surgery]
- Percentage of doses taken at 3 months [Time frame: at 3 months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospices Civils de Lyon — Lyon
Identifiers
NCT: NCT05202964 · 69HCL21_0905 · 2021-A02134-37