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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections
- ClinicalTrials.gov ID
- NCT05202964
- Acronym / sponsor ID
- OTABIO / 69HCL21_0905
- Keywords
- Tolerance, Adherence, Antibiotic, BJI, adverse effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 13 Sep 2028 (estimated)
- Study completion
- 13 Sep 2028 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerance and adherence to oral antibiotics in patients managed for BJI | – | Other: Tolerance and adherence to oral antibiotics in patients managed for BJIPatients having a BJI treated by surgery and taking at least one oral antibiotic after the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having a BJI treated by at least one oral antibiotic after a surgery
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tolerance and adherence to oral antibiotics in patients managed for BJIAdherence 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. | Other | Tolerance and adherence to oral antibiotics in patients managed for BJI |
Primary outcome
Percentage of doses taken at 6 weeks
Time frame: 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
Time frame: at 3 months after surgery
Ratio of the number of doses taken over the theoretical number of doses to be taken over the period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Drug-Related Side Effects and Adverse Reactions
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie MIRABET principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tristan FERRY, MD, PHD (4 26 73 29 38 ext. +33, tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of doses taken at 6 weeks (time frame: At 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.