Not yet recruiting NCT07058415
Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stool sample 1, Stool sample 2, Stool sample 3.
- Who it may be relevant to
- Registry conditions: Osteoarticular Material Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Osteoarticular Infections on Equipment: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
Overview
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).
Interventions
- Other Stool sample 1
Stool sampling at D0 for having baseline reference - Other Stool sample 2
Stool sampling at D5 to study the impact of antibiotics on microbiota - Other Stool sample 3
Stool sampling at DX+28 to study the impact of antibiotics on microbiota
Primary outcome measures
- 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]
Secondary outcome measures (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 [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]
Eligibility criteria
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, 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 4 centers
- Ch Antibes — Antibes
- Ch Cannes — Cannes
- Ch Grasse — Grasse
- CHU de NICE — Nice
Identifiers
NCT: NCT07058415 · 22-CONS-01