Bone InfectionPROSEABNCT05927311
Side Effects of Antibiotics in Bone and Joint Infections
An observational study of Bone Infection and Joint Infection, run by University Hospital, Tours at 1 site in France.
Trial summary
Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Infection, Joint Infection
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2023to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patient over 18 years of age with an osteoarticular infection requiring antibiotherapy of 6 weeks or more
Who may be able to join
- Patient over 18 years of age
- Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
- Oral antibiotic therapy (minimum 4 weeks)
Who cannot join
- Opposition to data processing
- Patient under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study : Side Effects of Antibiotics in Bone and Joint Infections
Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
Read the detailed description
Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.
The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.
- Conditions
- Bone Infection, Joint Infection
- Keywords
- antibiotherapy, adverse events
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reactions
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Measured: Day 15
Adverse reactions
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Measured: Day 45
Adverse reactions
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Measured: Day 90
Secondary outcomes (4)
Treatment failure
In the absence of the criterion of certainty, probable failure is defined by clinical (fever, pain, functional impotence, etc.), radiological (edging, signs of osteitis, etc.) and biological (increased CRP, hyperleukocytosis in the absence of any other cause) arguments.
Measured: Day 15, day 45, day 90
compliance of treatment
Analysis of compliance and discontinuation of treatment, taking into account the adverse reaction profile.
Measured: Day 15, day 45, day 90
Drug interactions
Analysis of drug interactions between antibiotic therapy for BJI and the patient's usual treatments at initiation and at each follow-up consultation.
Measured: Day 15, day 45, day 90
EQ5D-5L
Quality of life will be assessed using the EuroQol 5 dimensions-5 levels (EQ-5D-5L) score questionnaire at the end of follow-up. Each one of the 5 scales goes from 1 to 5, 1 being the best possible outcome while 5 being the worst.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Aug 2023
- Primary completion7 Aug 2024
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion LACASSE, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927311
- Sponsor's protocol ID
- DR230121-PROSEAB
- Acronym
- PROSEAB
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study : Side Effects of Antibiotics in Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT05927311
- Acronym / sponsor ID
- PROSEAB / DR230121-PROSEAB
- Conditions
- Bone Infection, Joint Infection
- Keywords
- antibiotherapy, adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 3 Jul 2023 (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.
Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
Detailed description
Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.
The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.
The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years of age with an osteoarticular infection requiring antibiotherapy of 6 weeks or more
Key inclusion criteria (3 listed)
- Patient over 18 years of age
- Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
- Oral antibiotic therapy (minimum 4 weeks)
Key exclusion criteria (2 listed)
- Opposition to data processing
- Patient under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse reactions
Time frame: Day 15
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Adverse reactions
Time frame: Day 45
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
Adverse reactions
Time frame: Day 90
Changes in number, severity of clinical and biological adverse reactions to antibiotics reported by patients during follow-up of osteoarticular infections.
4 secondary outcomes
Treatment failure
Time frame: Day 15, day 45, day 90
compliance of treatment
Time frame: Day 15, day 45, day 90
Drug interactions
Time frame: Day 15, day 45, day 90
EQ5D-5L
Time frame: Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Marion LACASSE principal investigator
CHRU de Tours
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 Bone Infection and Joint Infection, run by University Hospital, Tours 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reactions (time frame: Day 15). The study lists 3 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 6 May 2026.