Bone and Joint InfectionNCT02817711
Lyon BJI Cohort Study
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bone and Joint Infection
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2002to Jul 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study includes all patients who have a bone and joint infection, with or without implant, and treated in the department of infectious disease at the HCL.
Who may be able to join
- patients with bone or joint infection, with or without implant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse
Lyon, 69004
Eugénie Mabrut, ARC, (0)426732938 ext. +33, eugenie.mabrut@chu-lyon.fr
Tristan Ferry, MD, PHD, (0)472071107 ext. +33, tristan.ferry@chu-lyon.fr
About this study
The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.
Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.
Read more
Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.
This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.
- Conditions
- Bone and Joint Infection
- Keywords
- infection, bone and joint infection, relapse, adverse event
- Medical subject headings
- Infections, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure in patients with bone or joint infection
Up to 30% of patients experience a relapse, even when the treatment is considered as optimal. This Cohort will improve knowledges about the mechanisms of treatment failure by collecting data concerning infectious disease, surgery and microbiology and by analysing the cases where treatment failed. Treatment failure is defined by local clinical and/or microbiological relapse, under treatment or after treatment discontinuation.
Measured: 2 years
Secondary outcomes (1)
Occurrence of serious adverse events in patients with bone or joint infection
The duration of the antibiotic treatment is long : several weeks, several months or even several years in some cases. Patients are then exposed to adverse events. The data concerning theses adverse events are collected in this Cohort : molecule, dosage, description of the adverse event, a change in treatment. A severity grade is allocated to every adverse event, based on the " Common Terminology Criteria for Adverse Events ". This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term (from 1 to 5). Severe adverse events have a grade >=3.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJul 2002
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, MD, PhD, Principal investigator, Centre de reference des infections ostéo-articulaires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817711
- Sponsor's protocol ID
- 69HCL16_0388
- Status last verified
- Jan 2017
- First submitted
- 27 Jun 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyon BJI Cohort Study
- ClinicalTrials.gov ID
- NCT02817711
- Acronym / sponsor ID
- 69HCL16_0388
- Conditions
- Bone and Joint Infection
- Keywords
- infection, bone and joint infection, relapse, adverse event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- 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.
The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.
Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.
Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.
This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes all patients who have a bone and joint infection, with or without implant, and treated in the department of infectious disease at the HCL.
Key inclusion criteria (1 listed)
- patients with bone or joint infection, with or without implant
Key exclusion criteria (0 listed)
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
Treatment Failure in patients with bone or joint infection
Time frame: 2 years
Up to 30% of patients experience a relapse, even when the treatment is considered as optimal. This Cohort will improve knowledges about the mechanisms of treatment failure by collecting data concerning infectious disease, surgery and microbiology and by analysing the cases where treatment failed. Treatment failure is defined by local clinical and/or microbiological relapse, under treatment or after treatment discontinuation.
1 secondary outcome
Occurrence of serious adverse events in patients with bone or joint infection
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Related InfoLink provided by the sponsor.
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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.
Tristan Ferry, MD, PhD principal investigator
Centre de reference des infections ostéo-articulaires
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 and Joint Infection, 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugénie Mabrut, ARC ((0)426732938 ext. +33, eugenie.mabrut@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure in patients with bone or joint infection (time frame: 2 years). 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 4 Jan 2017.