Bone and Joint InfectionNCT03852784
Osteoarticular Infections With Pneumococcal
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- Bone and joint infection with Streptococcus peumoniae
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Apr 2020
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: patients having had a bone and joint infection with S pneumoniae, with or without device managed at the Croix-Rousse hospital
Who may be able to join
- patients having had a bone and joint infection with S pneumoniae, with or without device.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.
- Conditions
- Bone and Joint Infection
- Being tested
- Bone and joint infection with Streptococcus peumoniae
- Keywords
- Bone and Joint Infection, Streptococcus peumoniae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone and joint infection with Streptococcus peumoniaeOther
description of the osteoarticular infection with Streptococcus peumoniae
| Study group | Role | What they receive |
|---|---|---|
| Bone and joint infection with Streptococcus peumoniae | Patients having had an osteoarticular infection with Streptococcus peumoniae Receives: Other: Bone and joint infection with Streptococcus peumoniae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description and rate of bone or joint infection with S. pneumoniae
Description of the type of infection due to S. pneumoniae : patients and type of implant, profile of the bacterium associated in the infection, medical and chirurgical treatment
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes (1)
Rate of Treatment Failure
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Apr 2020
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
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan Ferry, Md,PhD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852784
- Sponsor's protocol ID
- 19-074
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2019
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarticular Infections With Pneumococcal
- ClinicalTrials.gov ID
- NCT03852784
- Acronym / sponsor ID
- 19-074
- Conditions
- Bone and Joint Infection
- Keywords
- Bone and Joint Infection, Streptococcus peumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 25 Feb 2019 (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.
Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone and joint infection with Streptococcus peumoniae | – | Other: Bone and joint infection with Streptococcus peumoniaePatients having had an osteoarticular infection with Streptococcus peumoniae |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had a bone and joint infection with S pneumoniae, with or without device managed at the Croix-Rousse hospital
Key inclusion criteria (1 listed)
- patients having had a bone and joint infection with S pneumoniae, with or without device.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Bone and joint infection with Streptococcus peumoniaedescription of the osteoarticular infection with Streptococcus peumoniae | Other | Bone and joint infection with Streptococcus peumoniae |
Primary outcome
Description and rate of bone or joint infection with S. pneumoniae
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Description of the type of infection due to S. pneumoniae : patients and type of implant, profile of the bacterium associated in the infection, medical and chirurgical treatment
1 secondary outcome
Rate of Treatment Failure
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
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 22 Sep 2023.
- Related InfoLink provided by the sponsor.
- 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.
Tristan Ferry, Md,PhD study director
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 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 1 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 22 Sep 2023. 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?
Description and rate of bone or joint infection with S. pneumoniae (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption). 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 22 Sep 2023.