Drug-Related Side Effects and Adverse ReactionsOTABIONCT05202964
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
An observational study of Drug-Related Side Effects and Adverse Reactions and Treatment Adherence and Compliance, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
- What is being tested?
- Tolerance and adherence to oral antibiotics in patients managed for BJI
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2024to 13 Sep 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having a BJI treated by at least one oral antibiotic after a surgery
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Tristan FERRY, 4 26 73 29 38 ext. +33, tristan.ferry@chu-lyon.fr
Valérie MIRABET
About this study
Official title: Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections
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.
- Being tested
- Tolerance and adherence to oral antibiotics in patients managed for BJI
- Keywords
- Tolerance, Adherence, Antibiotic, BJI, adverse effect
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolerance and adherence to oral antibiotics in patients managed for BJIOther
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 group | Role | What they receive |
|---|---|---|
| Tolerance and adherence to oral antibiotics in patients managed for BJI | Patients having a BJI treated by surgery and taking at least one oral antibiotic after the surgery Receives: Other: Tolerance and adherence to oral antibiotics in patients managed for BJI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 weeks after surgery
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
Measured: at 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start13 Jun 2024
- Primary completion13 Sep 2028 (estimated)
- Study completion13 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Related Side Effects and Adverse ReactionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie MIRABET, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202964
- Sponsor's protocol ID
- 69HCL21_0905
- Other IDs
- 2021-A02134-37
- Acronym
- OTABIO
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No