Bone and Joint InfectionOSIRISNCT03011502
InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
A study testing Biological samples collection of blood and feces in people with Bone and Joint Infection, run by MaaT Pharma at 5 sites in France.
Trial summary
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation. As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone and Joint Infection
- What is being tested?
- Biological samples collection of blood and feces
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2016to 27 Mar 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled
- The subject is willing, able to understand and comply to the protocol requirement
- More than 18-years-old
- Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment
- Subject signed Inform Consent Form
Who cannot join
- Pregnancy
- Severe disease with a life expectancy < 3 months
- Antibiotherapy in the 14 days before inclusion in the study
- Patient non-affiliated to health care system
- Patient under the power of law
- Guardianship, curators patients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Bordeaux
Bordeaux
HCL Croix-Rousse
Lyon
CHU de Nantes
Nantes
GH Diaconesses-Croix Saint Simon
Paris
CH Tourcoing
Tourcoing
About this study
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.
As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.
Read more
MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.
To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.
Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.
- Conditions
- Bone and Joint Infection
- Being tested
- Biological samples collection of blood and feces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collection of blood and fecesOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Other: Biological samples collection of blood and feces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of intensity and frequency of Diarrheic Symptoms
Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)
Measured: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
Secondary outcomes (1)
Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method
Measured: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion27 Mar 2018
- Study completion27 Mar 2018
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaaT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, MD, PhD, Principal investigator, Hôpitaux civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011502
- Sponsor's protocol ID
- MPBJI01
- Acronym
- OSIRIS
- Status last verified
- Nov 2017
- First submitted
- 27 Dec 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
- ClinicalTrials.gov ID
- NCT03011502
- Acronym / sponsor ID
- OSIRIS / MPBJI01
- Conditions
- Bone and Joint Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- MaaT PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 5 Jan 2017 (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.
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.
As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.
MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.
To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.
Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Biological samples collection of blood and feces |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled
- The subject is willing, able to understand and comply to the protocol requirement
- More than 18-years-old
- Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment
- Subject signed Inform Consent Form
Key exclusion criteria (6 listed)
- Pregnancy
- Severe disease with a life expectancy < 3 months
- Antibiotherapy in the 14 days before inclusion in the study
- Patient non-affiliated to health care system
- Patient under the power of law
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 samples collection of blood and feces | Other | Experimental arm |
Primary outcome
Evolution of intensity and frequency of Diarrheic Symptoms
Time frame: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)
1 secondary outcome
Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method
Time frame: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)
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 5 Apr 2018.
- Individual participant dataSharing planned: Yes
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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
Hôpitaux civils de Lyon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples collection of blood and feces in people with Bone and Joint Infection, run by MaaT Pharma at 5 sites 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 5 inclusion and 6 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Evolution of intensity and frequency of Diarrheic Symptoms (time frame: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)). 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 5 Apr 2018.