Bone and Joint InfectionNCT03611634
Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
An observational study of Bone and Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. 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?
- BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2018to 19 Jul 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine
Who may be able to join
- Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
- Patients not opposed to participate to the study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA
About this study
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.
However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.
The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.
- Conditions
- Bone and Joint Infection
- Being tested
- BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE
- Keywords
- gut microbiote, bone and joint infection, antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTEOther
collection of saddles
| Study group | Role | What they receive |
|---|---|---|
| BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE | The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance. Receives: Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE
The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start19 Jul 2018
- Primary completion19 Jul 2023 (estimated)
- Study completion19 Jul 2024 (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
- 20 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
- Tristan Ferry, Md,PhD, Principal investigator, Hospices Civils de Lyon - Hopital de la Croix Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611634
- Sponsor's protocol ID
- 18-126
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2018
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
- ClinicalTrials.gov ID
- NCT03611634
- Acronym / sponsor ID
- 18-126
- Conditions
- Bone and Joint Infection
- Keywords
- gut microbiote, bone and joint infection, antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 19 Jul 2023 (estimated)
- Study completion
- 19 Jul 2024 (estimated)
- First posted
- 2 Aug 2018 (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.
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.
However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.
The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE | – | Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTEThe aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine
Key inclusion criteria (2 listed)
- Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
- Patients not opposed to participate to the study
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 |
|---|---|---|
| BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTEcollection of saddles | Other | BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE |
Primary outcome
BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE
Time frame: 36 months
The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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 principal investigator
Hospices Civils de Lyon - Hopital de la Croix Rousse
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 2 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 30 Aug 2021. 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 (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?
BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE (time frame: 36 months). 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 30 Aug 2021.