Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria

Официальное название

Osteoarticular Infections on Equipment: Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria

Обзор

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).

Вмешательства

• Другое Stool sample 1
  Stool sampling at D0 for having baseline reference
• Другое Stool sample 2
  Stool sampling at D5 to study the impact of antibiotics on microbiota
• Другое Stool sample 3
  Stool sampling at DX+28 to study the impact of antibiotics on microbiota

Первичные конечные точки

• 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 [Срок оценки: At Day 5 after starting treatment]

Вторичные конечные точки (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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 4 months]
• Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 4 центра

• Ch Antibes — Antibes
• Ch Cannes — Cannes
• Ch Grasse — Grasse
• CHU de NICE — Nice

Идентификаторы

NCT: NCT07058415 · 22-CONS-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗