Infection, BacterialGUMIBONENCT03633188
Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection
A study testing Patients treated by antibiotherapy in people with Infection, Bacterial, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Bone and joint infections (BJI) is a public health issue in industrialized countries. Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Patients treated by antibiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Jul 2018to 28 Aug 2020
- 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
- The subject is willing, able to understand and comply to the protocol requirement
- More than 18-years-old
- Subject with suspicion of implant-related BJI within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months
- Subject signed Inform Consent Form
- Contraception for women of childbearing age
Who cannot join
- Pregnancy
- Severe disease with a life expectancy < 3months
- Any antibiotherapy treated all diseases in the 14 days before inclusion
- Guardianship, curatorship patients
- Patient non-affiliated to health care system
- Patient under the power of law
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital de la Croix Rousse-Service de chirurgie orthopédique
Lyon, 69004
Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales
Lyon, 69004
Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique
Pierre-Bénite, 69310
Centre Hospitalier Lyon Sud-Service des maladies infectieuses
Pierre-Bénite, 69310
About this study
Bone and joint infections (BJI) is a public health issue in industrialized countries.
Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.
Read more
A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).
Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.
Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.
The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
- Conditions
- Infection, Bacterial
- Being tested
- Patients treated by antibiotherapy
- Keywords
- Bone and Joint Infections (BJI), gut dysbiosis, antimicrobial resistance, antibiotic resistance gene, mobile genetic elements
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients treated by antibiotherapyBiological
Biological samples (stool, blood, swabs) will be collected :
- Blood sampling (12 ml) at baseline (week 0) at the end of treatment (W6/W24),and 15 days after antibiotherapy stop (optional) (W8/W26),
- Feces collection at baseline (week 0) during antibiotic treatment (W2), at the end of treatment (W6/W24),15 days after antibiotherapy stop (W8/W26), and W26 after baseline
- Swab samples (nasal and rectal) at baseline at week 0 and at the end of treatment (W6/W24),
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by antibiotherapy | Experimental | 35 Patients treated by antibiotherapy for acute and subacute post-operative implant-associated BJI infections and among them 10 patients with Staphylococcus. aureus treated with antibiotics as part of their standard treatment procedure for metagenomic procedure. Receives: Biological: Patients treated by antibiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the gut microbiota after treatment
stools will be collected to perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Measured: from baseline to week 26
Secondary outcomes (8)
Assessment of the evolution of intensity of Diarrheic Symptoms
intensity of diarrheic symptoms will be collected at baseline, at the end of treatment (Week 6 or Week 24) and 15 days after antibiotic stop (Week 8 or Week 26)
Measured: from baseline to week 8 or week 26
Assessment of the evolution of frequency of Diarrheic Symptoms
frequency of diarrheic symptoms will be collected at baseline, at the end of treatment (Week 6 or Week 24) and 15 days after antibiotic stop (Week 8 or Week 26)
Measured: from baseline to week 8 or week 26
Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods
classic culture and quantification culture methods determined by microbiology analysis of the feces.
Feces will be collected at baseline and at the end of treatment
Measured: at week 6 or week 24
gut dysbiosis measured by Next Generation Sequencing (NGS)
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Microbiota sequencing will be done after DNA extraction. Composition of the microbiota will be screened in feces samples using the shotgun sequencing method to establish a total picture of the gut composition and diversity as well as evolution of the microbiome.
Measured: from baseline to week 26
severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS)
Severe Post-Antibiotic Dysbiosis lead to irreversible change in gut microbiota status and systemic consequences for the host.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Measured: from baseline to week 26
Identification of markers of the gut dysbiosis (inflammatory proteins) measured by Elisa techniques
ELISA techniques will be used to determine the concentration of 3 specific inflammatory stool epithelium proteins: zonulin, calprotectin and neopterin.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Measured: from baseline to week 26
Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D5L questionnaires
EQ-5D questionnaire has 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression". All dimensions are described by 5 (EQ-5D-5L) problem levels corresponding to patient response choices.
Questionnaire will be completed at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Measured: from baseline to week 26
Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D3L questionnaire
EQ-5D questionnaire has 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression". All dimensions are described by 3 (EQ-5D-3L) problem levels corresponding to patient response choices. In France, only the EQ-5D-3L has been validated, not yet the EQ-5D-5L which has only been translated.
Questionnaire will be completed at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Measured: from baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start19 Jul 2018
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Why it stopped: the study had to be stopped because the period of the Financial contract was over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lyon
- Responsible party
- Sponsor
- Investigators
- Tristan FERRY, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633188
- Sponsor's protocol ID
- 69HCL17_0652
- Other IDs
- 2017-A02813-50
- Acronym
- GUMIBONE
- Status last verified
- Feb 2021
- First submitted
- 17 Jul 2018
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT03633188
- Acronym / sponsor ID
- GUMIBONE / 69HCL17_0652
- Conditions
- Infection, Bacterial
- Keywords
- Bone and Joint Infections (BJI), gut dysbiosis, antimicrobial resistance, antibiotic resistance gene, mobile genetic elements
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study had to be stopped because the period of the Financial contract was over
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- University of Lyon
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 16 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.
Bone and joint infections (BJI) is a public health issue in industrialized countries.
Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.
A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).
Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.
Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.
The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by antibiotherapy | Experimental | Biological: Patients treated by antibiotherapy35 Patients treated by antibiotherapy for acute and subacute post-operative implant-associated BJI infections and among them 10 patients with Staphylococcus. aureus treated with antibiotics as part of their standard treatment procedure for metagenomic procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is willing, able to understand and comply to the protocol requirement
- More than 18-years-old
- Subject with suspicion of implant-related BJI within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months
- Subject signed Inform Consent Form
- Contraception for women of childbearing age
Key exclusion criteria (6 listed)
- Pregnancy
- Severe disease with a life expectancy < 3months
- Any antibiotherapy treated all diseases in the 14 days before inclusion
- Guardianship, curatorship patients
- Patient non-affiliated to health care system
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 |
|---|---|---|
| Patients treated by antibiotherapyBiological samples (stool, blood, swabs) will be collected : * Blood sampling (12 ml) at baseline (week 0) at the end of treatment (W6/W24),and 15 days after antibiotherapy stop (optional) (W8/W26), * Feces collection at baseline (week 0) during antibiotic treatment (W2), at the end of treatment (W6/W24),15 days after antibiotherapy stop (W8/W26), and W26 after baseline * Swab samples (nasal and rectal) at baseline at week 0 and at the end of treatment (W6/W24), | Biological | Patients treated by antibiotherapy |
Primary outcome
change in the gut microbiota after treatment
Time frame: from baseline to week 26
stools will be collected to perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus. Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
8 secondary outcomes
Assessment of the evolution of intensity of Diarrheic Symptoms
Time frame: from baseline to week 8 or week 26
Assessment of the evolution of frequency of Diarrheic Symptoms
Time frame: from baseline to week 8 or week 26
Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods
Time frame: at week 6 or week 24
gut dysbiosis measured by Next Generation Sequencing (NGS)
Time frame: from baseline to week 26
severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS)
Time frame: from baseline to week 26
Identification of markers of the gut dysbiosis (inflammatory proteins) measured by Elisa techniques
Time frame: from baseline to week 26
Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D5L questionnaires
Time frame: from baseline to week 26
Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D3L questionnaire
Time frame: from baseline to week 26
Results and safety
The study was stopped early (reason given: the study had to be stopped because the period of the Financial contract was over). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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, Pr principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients treated by antibiotherapy in people with Infection, Bacterial, run by Hospices Civils de Lyon at 4 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: stopped early, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: the study had to be stopped because the period of the Financial contract was over). Results are not available in the source record.
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?
change in the gut microbiota after treatment (time frame: from baseline to week 26). 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 Feb 2021.