Staphylococcus Aureus InfectionRELAPSTAPHNCT04712123
Recurrent S. Aureus Infections in Osteoarticular Infections
An observational study of Staphylococcus Aureus Infection and Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Aureus Infection, Bone and Joint Infection
- What is being tested?
- relapse due to S. aureus
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2021to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients having had an osteoarticular infection with or without material due to S. aureus and treated at CRIOAc Lyon, presenting a recurrence of S. aureus infection
Who may be able to join
- patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA, 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr
About this study
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.
The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus
- Being tested
- relapse due to S. aureus
- Keywords
- Staphylococcus Aureus Infection, Bone and Joint Infection, relapse
- Medical subject headings
- Staphylococcal Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relapse due to S. aureusOther
to find out if it is the same S. aureus in both infections
| Study group | Role | What they receive |
|---|---|---|
| relapse due to S. aureus | patients having had an initial infection due to S. aureus and who present a relapse with persistence of S. aureus Receives: Other: relapse due to S. aureus |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients having had an osteoarticular infection due to S. aureus
proportion of patients having had an osteoarticular infection due to S. aureus
Measured: between 2015 and 2020
Description of patients having had an osteoarticular infection due to S. aureus
type of patients: age, BMI, comorbidities...
Measured: between 2015 and 2020
Description of Bone and Joint Iinfection/Prosthesis Joint Infection
implant or prosthesis or not, acute/ chronic, bacteriology
Measured: between 2015 and 2020
Secondary outcomes (2)
rate of patients having had a relapse due to persistence of S. aureus
proportion of patients having had an osteoarticular infection due persistence of S. aureus
Measured: between 2015 and 2020
rate of S. aureus strain identical between the initial episode and the relapse
proportion of relapse due to the same strain of S. aureus than in the initial episode
Measured: between 2015 and 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Aug 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712123
- Sponsor's protocol ID
- 281
- Acronym
- RELAPSTAPH
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2022
- 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 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent S. Aureus Infections in Osteoarticular Infections
- ClinicalTrials.gov ID
- NCT04712123
- Acronym / sponsor ID
- RELAPSTAPH / 281
- Keywords
- Staphylococcus Aureus Infection, Bone and Joint Infection, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.
The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| relapse due to S. aureus | – | Other: relapse due to S. aureuspatients having had an initial infection due to S. aureus and who present a relapse with persistence of S. aureus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients having had an osteoarticular infection with or without material due to S. aureus and treated at CRIOAc Lyon, presenting a recurrence of S. aureus infection
Key inclusion criteria (1 listed)
- patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| relapse due to S. aureusto find out if it is the same S. aureus in both infections | Other | relapse due to S. aureus |
Primary outcome
rate of patients having had an osteoarticular infection due to S. aureus
Time frame: between 2015 and 2020
proportion of patients having had an osteoarticular infection due to S. aureus
Description of patients having had an osteoarticular infection due to S. aureus
Time frame: between 2015 and 2020
type of patients: age, BMI, comorbidities...
Description of Bone and Joint Iinfection/Prosthesis Joint Infection
Time frame: between 2015 and 2020
implant or prosthesis or not, acute/ chronic, bacteriology
2 secondary outcomes
rate of patients having had a relapse due to persistence of S. aureus
Time frame: between 2015 and 2020
rate of S. aureus strain identical between the initial episode and the relapse
Time frame: between 2015 and 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- 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.
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 Staphylococcus Aureus Infection and 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. 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 Eugenie Mabrut, CRA (04 26 73 29 38, 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?
rate of patients having had an osteoarticular infection due to S. aureus (time frame: between 2015 and 2020). 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 20 Jan 2022.