Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
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
Trial population
patients having a BJI treated by at least one oral antibiotic after a surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tolerance and adherence to oral antibiotics in patients managed for BJI
Other interventionAdherence 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Tolerance and adherence to oral antibiotics in patients managed for BJI1 intervention
Trial outcomes
Primary outcomes
1
Percentage of doses taken at 6 weeks
Ratio of the number of doses taken over the theoretical number of doses to be taken over the period
Time frame
At 6 weeks after surgery2
Percentage of doses taken at 3 months
Ratio of the number of doses taken over the theoretical number of doses to be taken over the period
Time frame
at 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov