Osteoarticular Material InfectionHOPENCT07058415
Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
A study testing Stool sample 1, Stool sample 2 and Stool sample 3 in people with Osteoarticular Material Infection, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
In the event of suspected osteoarticular material infection (OAMI), broad-spectrum probabilistic antibiotic therapy is recommended immediately after revision surgery. There are no efficacy data to suggest that any particular to favour any particular molecule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarticular Material Infection
- What is being tested?
- Stool sample 1, Stool sample 2 and Stool sample 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesFrance
- Study dates
- Jul 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Indication for prosthetic revision (PTG, PUC, PTH or hip hemiarthroplasty, PTE) or internal osteosynthesis with suspicion of IOAM following the opinion of a Réunion de concertation Pluridisciplinaire (RCP) on complex osteoarticular infections
- Normal CPK level according to laboratory standard
- Social security affiliation
- Signature of informed consent
- Negative pregnancy test for women of childbearing age.
Who cannot join
- Antibiotic therapy in the 3 months prior to inclusion
- Clinical or radiological signs making HAI highly probable: scar discharge and/or peri-scar cellulitis fistula or abscess, bacteremia
- positive bacterial culture from joint puncture or biopsy prior to revision
- Chronic inflammatory bowel disease.
- Previous surgical resection of small intestine or colon.
- Hypersensitivity to daptomycin or any of its excipients.
Show all 21Show fewer
- Hypersensitivity to cefepime or any of its excipients or to other beta-lactamins.
- Hypersensitivity to piperacillin+tazobactam or to any of the excipients or to other beta-lactamines.
- Hypersensitivity to ceftobiprole or to any of the excipients or to other beta-lactamines.
- Renal insufficiency with GFR < 50ml/min/1.73 m2 (CKD-EPI).
- Treatment with bosentan.
- Treatment with probenecid.
- Pre-existing seizure disorder.
- Contraindication to L-arginine, acidosis, hyperkalemia that cannot be corrected.
- Treatment with HMG-CoA reductase inhibitors.
- Treatment with statins (pitavastin, pravastatin, rosuvastatin) or glyburide.
- Patients in a medical emergency.
- Pregnant or breast-feeding women.
- Patient participating in another ongoing trial.
- Mental state rendering the patient incapable of understanding this research.
- Patient deprived of liberty by administrative or judicial decision.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Irit TOUITOU contact
France4 sites
Ch Antibes
Antibes
Sonia DJEDID, Sonia.djedid@ch-antibes.fr
Eric DENIS
Ch Cannes
Cannes
Nathalie DOUX, n.doux@ch-cannes.fr
Matteo VASSALLO
Ch Grasse
Grasse
Geneviève GOZZERINO, ge.gozzerino@ch-grasse.fr
Cécile CAISSO
CHU de NICE
Nice
Irit TOUITOU, Touitou.i@chu-nice.fr
Johan COURJON
About this study
Official title: Osteoarticular Infections on Equipment: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
In the event of suspected osteoarticular material infection (OAMI), broad-spectrum probabilistic antibiotic therapy is recommended immediately after revision surgery. There are no efficacy data to suggest that any particular to favour any particular molecule. However, the choice may depend on the impact on the microbiota and on Enterobacteriaceae colonization with multi-resistant Enterobacteriaceae. Our aim is to evaluate three different strategies efepime+daptomycin C+D, piperacillin-tazobactam+daptomycin (PT+D) and ceftobiprole (CFB).
- Conditions
- Osteoarticular Material Infection
- Being tested
- Stool sample 1, Stool sample 2, Stool sample 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sample 1Other
Stool sampling at D0 for having baseline reference
Stool sample 2Other
Stool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3Other
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
| Study group | Role | What they receive |
|---|---|---|
| Céfépime + Daptomycine | Active comparator | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). Receives: Other: Stool sample 1; Other: Stool sample 2; Other: Stool sample 3 |
| Pipéracilline-Tazobactam + Daptomycine | Active comparator | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). Receives: Other: Stool sample 1; Other: Stool sample 2; Other: Stool sample 3 |
| Ceftobiprole | Experimental | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). Receives: Other: Stool sample 1; Other: Stool sample 2; Other: Stool sample 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare changes in gut microbiota biodiversity between Day1 and Day5 between populations treated with C+D, PT+D and CFB in suspected Osteoarticular infection on equipment
using targeted metagenomics (16S rDNA)
Measured: At Day 5 after starting treatment
Secondary outcomes (6)
Compare the evolution between Day1/end of treatment+28 Days and between Day 5/end of treatment+28D of microbiota biodiversity of each patient population treated with different antibiotics for suspected Osteoarticular infection on equipment
Simpson index,
Measured: Up to 4 months
Compare the rate of acquisition of multidrug-resistant extended-spectrum beta-lactamase-producing intestinal Enterobacteria between antibiotic strategies on samples at Day5 and DX+28 in patients with no multidrug-resistant Enterobacteria at Day1.
Stool culture on a selective medium at Day1, Day5 and Day X+28
Measured: Up to 4 months
Compare the rate of acquisition of carbapenemase-producing intestinal multi-resistant Enterobacteriaceae (EPC) between antibiotic strategies on samples taken at D5 and DX+28 in patients with no multi-resistant Enterobacteria at D1.
The appearance of EPC-type multi-resistant Enterobacteriaceae will be determined by stool culture on a selective medium selective medium (mSuperCARBA, MAST diagnostic) at D1, D5 and DX+28.
Measured: Up to 4 months
Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection.
Inadequacy of one of the three probabilistic strategies will be defined by a documented infection with a bacterium resistant to both antibiotics in the case of dual therapy, or to ceftobiprole in the case of monotherapy.
Measured: Up to 4 months
Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.
Shannon index
Measured: Up to 4 months
Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.
Piélou equitability index
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study startJul 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarticular Material InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, randomized, multicentric clinical trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058415
- Sponsor's protocol ID
- 22-CONS-01
- Acronym
- HOPE
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarticular Infections on Equipment: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
- ClinicalTrials.gov ID
- NCT07058415
- Acronym / sponsor ID
- HOPE / 22-CONS-01
- Conditions
- Osteoarticular Material Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Jul 2025 (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.
In the event of suspected osteoarticular material infection (OAMI), broad-spectrum probabilistic antibiotic therapy is recommended immediately after revision surgery. There are no efficacy data to suggest that any particular to favour any particular molecule. However, the choice may depend on the impact on the microbiota and on Enterobacteriaceae colonization with multi-resistant Enterobacteriaceae. Our aim is to evaluate three different strategies efepime+daptomycin C+D, piperacillin-tazobactam+daptomycin (PT+D) and ceftobiprole (CFB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparative, randomized, multicentric clinical trial
| Arm | Type | Receives |
|---|---|---|
| Céfépime + Daptomycine | Active comparator | Other: Stool sample 1, Other: Stool sample 2, Other: Stool sample 3First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
| Pipéracilline-Tazobactam + Daptomycine | Active comparator | Other: Stool sample 1, Other: Stool sample 2, Other: Stool sample 3First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
| Ceftobiprole | Experimental | Other: Stool sample 1, Other: Stool sample 2, Other: Stool sample 3First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Indication for prosthetic revision (PTG, PUC, PTH or hip hemiarthroplasty, PTE) or internal osteosynthesis with suspicion of IOAM following the opinion of a Réunion de concertation Pluridisciplinaire (RCP) on complex osteoarticular infections
- Normal CPK level according to laboratory standard
- Social security affiliation
- Signature of informed consent
Key exclusion criteria (21 listed)
- Antibiotic therapy in the 3 months prior to inclusion
- Clinical or radiological signs making HAI highly probable: scar discharge and/or peri-scar cellulitis fistula or abscess, bacteremia
- positive bacterial culture from joint puncture or biopsy prior to revision
- Chronic inflammatory bowel disease.
- Previous surgical resection of small intestine or colon.
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 |
|---|---|---|
| Stool sample 1Stool sampling at D0 for having baseline reference | Other | Ceftobiprole, Céfépime + Daptomycine, Pipéracilline-Tazobactam + Daptomycine |
| Stool sample 2Stool sampling at D5 to study the impact of antibiotics on microbiota | Other | Ceftobiprole, Céfépime + Daptomycine, Pipéracilline-Tazobactam + Daptomycine |
| Stool sample 3Stool sampling at DX+28 to study the impact of antibiotics on microbiota | Other | Ceftobiprole, Céfépime + Daptomycine, Pipéracilline-Tazobactam + Daptomycine |
Primary outcome
Compare changes in gut microbiota biodiversity between Day1 and Day5 between populations treated with C+D, PT+D and CFB in suspected Osteoarticular infection on equipment
Time frame: At Day 5 after starting treatment
using targeted metagenomics (16S rDNA)
6 secondary outcomes
Compare the evolution between Day1/end of treatment+28 Days and between Day 5/end of treatment+28D of microbiota biodiversity of each patient population treated with different antibiotics for suspected Osteoarticular infection on equipment
Time frame: Up to 4 months
Compare the rate of acquisition of multidrug-resistant extended-spectrum beta-lactamase-producing intestinal Enterobacteria between antibiotic strategies on samples at Day5 and DX+28 in patients with no multidrug-resistant Enterobacteria at Day1.
Time frame: Up to 4 months
Compare the rate of acquisition of carbapenemase-producing intestinal multi-resistant Enterobacteriaceae (EPC) between antibiotic strategies on samples taken at D5 and DX+28 in patients with no multi-resistant Enterobacteria at D1.
Time frame: Up to 4 months
Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection.
Time frame: Up to 4 months
Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.
Time frame: Up to 4 months
Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks.
Time frame: Up to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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.
Irit TOUITOU contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool sample 1, Stool sample 2 and Stool sample 3 in people with Osteoarticular Material Infection, run by Centre Hospitalier Universitaire de Nice 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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan COURJON (0492035877, courjon@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare changes in gut microbiota biodiversity between Day1 and Day5 between populations treated with C+D, PT+D and CFB in suspected Osteoarticular infection on equipment (time frame: At Day 5 after starting treatment). 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 22 Jun 2026.