Prospective Cohort Study on Patients With Tedizolid Prolonged Therapy for Orthopedic Device Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Retrobulbar optic nevritis
研究概览
简要总结
Pilot study the aim of which is to obtain reliable data on the tolerance, compliance and efficacy of Tedizolid used as prolonged (≥ 6 weeks) monotherapy or in combination therapy for the treatment of patients with orthopedic device infections due to Gram positive cocci.
详细描述
Background: The antibiotic treatment of patients with orthopedic device infections (e.g. prosthetic joint and osteosynthesis) is limited by the tolerance of prolonged administration of antibiotics and the high level of antibiotic resistance of some pathogens.
The prolonged intravenous administration of antibiotics exposes the patients to the occurrence of adverse events and it is generally recommended to favor oral treatment provided high oral bioavailable agents can be used with regard to the patient's characteristics and the antibiotic susceptibility profile of the pathogens.
Gram positive cocci especially coagulase negative staphylococci (CoNS) are predominant bacteria responsible for orthopedic device infections. The use of the oxazolidinone agent Linezolid in these settings has been validated by some studies in particular in combination with Rifampin but both hematologic, neurologic and metabolic potential toxicity limits treatment durations of more than two to three weeks. The risk of drug-drug interaction with any product having a mono-amine-oxydase inhibitor (MAOI) activity is another limiting problem with Linezolid use.
In addition, the wide use of Linezolid has resulted in the emergence of CoNS carrying cfr genes responsible for high levels of Linezolid resistance. This is unfortunate as in many cases there is almost no other alternative for the oral treatment of orthopedic device infections due to these strains.
Tedizolid intrinsic properties may improve the oxazolidinone treatment long term safety. Plus tedizolid should be active on CoNS strains resistant to linezolid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient at least 18 years;
- •Orthopedic device infection defined according to the French recommendations published in 2009 (Med Mal Infect 2009; 39:745-774) for which TEDIZOLID treatment is proposed according to the investigator's decision;
- •Bacterial documentation of the infection will only be based on the results of reliable samples such as joint aspiration and peroperative samples.
- •Requiring TEDIZOLID administration as a single antibiotic therapy or in combination therapy including another agent with proven activity against the involved pathogen(s);
- •No contraindication to TEDIZOLID;
- •Provide a signed informed consent for the trial.
排除标准
- •pregnant women or of childbearing age without contraception, breastfeeding,
- •intolerance to TEDIZOLID;
- •allergy to LINEZOLID;
- •bactéria non susceptible to TEDIZOLID;
- •patient with uncertainty regarding the possibility to achieve one-year follow-up after the end of treatment.
研究组 & 干预措施
Tedizolid Phosphate 200 MG [Sivextro]
All included patients will receive prolonged (>= 6 weeks) tedizolid treatment given orally.
干预措施: Tedizolid Phosphate 200 MG [Sivextro] (Drug)
结局指标
主要结局
Retrobulbar optic nevritis
时间窗: From date of inclusion until 12 months after the end of treatment
will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Bone marrow toxicity
时间窗: From date of inclusion until 12 months after the end of treatment
assessed on the values of hemoglobin, leucocytes, neutrophils and platelets counts, will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Metabolic acidosis
时间窗: From date of inclusion until 12 months after the end of treatment
dyspnea of unknown origin ; pH \< 7.35 ; \[ HCO3- \] \< 22 mmol/L ; paCO2 \< 45 mmHg ; lactates \> 2 mmol/L, will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Peripheral neuropathy
时间窗: From date of inclusion until 12 months after the end of treatment
Paresthesia, dysesthesia, hypoesthesia, allodynia (confirmed by EMG examination), will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
Serotoninergic syndrome
时间窗: From date of inclusion until 12 months after the end of treatment
will be collected to determine the number of adverse event likely to be related to tedizolid treatment.
次要结局
未报告次要终点