Osteoarticular Infections on Equipment: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Stool sample 2 (Other)
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).
干预措施: Stool sample 1 (Other)
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).
干预措施: Stool sample 3 (Other)
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).
干预措施: Stool sample 1 (Other)
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).
干预措施: Stool sample 2 (Other)
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).
干预措施: Stool sample 3 (Other)
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).
干预措施: Stool sample 1 (Other)
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).
干预措施: Stool sample 2 (Other)
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).
干预措施: Stool sample 3 (Other)
结局指标
主要结局
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
时间窗: At Day 5 after starting treatment
using targeted metagenomics (16S rDNA)
次要结局
- 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.(Up to 4 months)
- 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(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.(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.(Up to 4 months)
- Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection.(Up to 4 months)