Bone and Joint InfectionNCT03796104
Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
An observational study of Bone and Joint Infection and Staphylococcus Aureus, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bone and Joint Infection, Staphylococcus Aureus
- What is being tested?
- Delta-haemolysin
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Dec 2023
- 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 99 years
- All sexes
- Adult, Older adult
Study population: patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone and joint infection reference Center between 2006 and 2018
Who may be able to join
- patients having implant infection due to S. aureus treated by DAIR
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Johanna Boulant, CRA contact
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA
About this study
The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants
- Conditions
- Bone and Joint Infection, Staphylococcus Aureus
- Being tested
- Delta-haemolysin
- Keywords
- Bone and Joint Infection, Staphylococcus Aureus, chronic infection
- Medical subject headings
- Staphylococcal Infections, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta-haemolysinOther
comparison of groups having infection with S. aureus with and without delta-haemolysin Production
| Study group | Role | What they receive |
|---|---|---|
| Deficiency of delta-hemolysine | Implant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency Receives: Other: Delta-haemolysin | |
| Presence of delta-hemolysine | Implant infected by Staphylococcus aureus with delta-haemolysin Production Receives: Other: Delta-haemolysin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus
patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups
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. Analyse of risk factor. Comparison between the 2 groups
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 posted8 Jan 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2023 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
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
- FLORENT VALOUR, Md,PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796104
- Sponsor's protocol ID
- 18-333
- Status last verified
- Apr 2023
- First submitted
- 4 Jan 2019
- Last updated
- 13 Apr 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Delta-haemolysin Production Deficiency in Staphylococcus Aureus on the Prognosis of Infected Implant Treated by DAIR
- ClinicalTrials.gov ID
- NCT03796104
- Acronym / sponsor ID
- 18-333
- Conditions
- Bone and Joint Infection, Staphylococcus Aureus
- Keywords
- Bone and Joint Infection, Staphylococcus Aureus, chronic infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jan 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.
The aim of this study is to determine if delta-haemolysin production deficiency of Staphylococcus aureus is a marker in favour of chronic infections on implants
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deficiency of delta-hemolysine | – | Other: Delta-haemolysinImplant infected by Staphylococcus aureus with delta-haemolysin Production Deficiency |
| Presence of delta-hemolysine | – | Other: Delta-haemolysinImplant infected by Staphylococcus aureus with delta-haemolysin Production |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having implant infection due to S. aureus treated by DAIR managed at the Lyon Bone and joint infection reference Center between 2006 and 2018
Key inclusion criteria (1 listed)
- patients having implant infection due to S. aureus treated by DAIR
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 |
|---|---|---|
| Delta-haemolysincomparison of groups having infection with S. aureus with and without delta-haemolysin Production | Other | Deficiency of delta-hemolysine, Presence of delta-hemolysine |
Primary outcome
Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
patients, profile of the bacterium, medical and chirurgical treatment, rate. comparison between the 2 groups
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- 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.
Johanna Boulant, CRA contact
FLORENT VALOUR, Md,PhD 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 Bone and Joint Infection and Staphylococcus Aureus, 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: status not confirmed, as of the sponsor's last update on 13 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Boulant, CRA (johanna.boulant@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of infection with or witout delta-haemolysin in Staphylococcus Aureus (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 13 Apr 2023.