Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
NCT ID: NCT07058415
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2025-09-30
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Céfépime + Daptomycine
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).
Stool sample 1
Stool sampling at D0 for having baseline reference
Stool sample 2
Stool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
Pipéracilline-Tazobactam + Daptomycine
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).
Stool sample 1
Stool sampling at D0 for having baseline reference
Stool sample 2
Stool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
Ceftobiprole
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).
Stool sample 1
Stool sampling at D0 for having baseline reference
Stool sample 2
Stool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
Interventions
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Stool sample 1
Stool sampling at D0 for having baseline reference
Stool sample 2
Stool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
Eligibility Criteria
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Inclusion Criteria
* 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
* 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, 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Ch Antibes
Antibes, , France
Ch Cannes
Cannes, , France
Ch Grasse
Grasse, , France
CHU de NICE
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-CONS-01
Identifier Type: -
Identifier Source: org_study_id
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