Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Mu… (NCT07058415) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
France75 participantsStarted 2026-07
Plain-language 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. 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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, pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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