EUCTR2006-005453-30-GB进行中（未招募）不适用
A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated with an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent has been obtained;
- •2.Between the ages of 18 and 80, inclusive;
- •3.Subject must have a diagnosis of PJI in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery;
- •4.Has one of the following microbiological identifiers of PJI:
- •a. Two confirmatory deep intra-operative cultures obtained at Surgery #1 from 4 or more independent surgical sites for staphylococci (e.g. S. aureus or CoNS); or
- •b. One culture positive for staphylococci (e.g. S. aureus or CoNS) from affected joint synovial fluid aspirate obtained within 6 weeks (42 days) prior to Surgery #1 with a confirmatory positive culture from 1 or more deep intra-operative surgical sites within 72 hours of Surgery #1; or
- •c. In the event intra-operative cultures are negative or remain pending after 72 hours, a patient may be considered for study participation if 2 Gram stains show Gram-positive pathogens or histopathological evidence of staphylococci is obtained within 72 hours following Surgery #1; or
- •d. Two positive blood cultures for staphylococci (e.g. S. aureus or CoNS) obtained from two independent peripheral sites within 48 hours prior to Surgery #1.
- •5.Subject, if female of childbearing potential, must be willing to practice reliable birth control measures (e.g., condoms or diaphragms together with a spermicidal foam or gel) during study treatment and for at least 28 days after completion of study medication and has a documented negative pregnancy test result within 72 hours prior to study medication administration
- •6.Subject must be willing to participate in the study, follow protocol study treatment regimen, and comply with all planned assessments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject is anticipated to have retention of the infected prosthetic joint, a one-stage prosthetic joint replacement procedure, or resection of the prosthetic joint and arthrodesis;
- •2.Subject has undergone a total revision for previous infection of the joint under study;
- •3. Subject has permanent intravascular prosthetic material in a site or sites other than the joint under study, includingsuch as heart valves, or pacemakers, and any other metalwork or prosthetic implant unless deemed acceptable by the Medical Monitor;
- •4.Subject is likely to require non-study systemic antibiotics effective against staphylococci for any other reason during the trial period from first dose of study medication through discharge from the hospital following Surgery #2;
- •5.Subject is anticipated to require oral antibiotic step-down or suppressive antibiotic therapy after EOT and through discharge from the hospital following Surgery #2;
- •6.Subject has a Creatinine Clearance <30 mL/min as determined by the Cockcroft-Gault equation using actual body weight;[Note: If CRCL drops below 30 mL/min while on treatment the Medical Monitor must be contacted. A decision will be made between the Medical Monitor and the Investigator on a case-by-case basis whether to discontinue a patient from the study.];
- •7.Subject has a significant hepatic dysfunction (AST/ALT =5 x ULN or total bilirubin =3.0mg/dL);
- •8.Subject is unable to discontinue HMG CoA reductase inhibitor therapy from randomization through the EOT visit;
- •9.Subject has a mixed Gram-positive and Gram-negative PJI or a pure Gram-negative PJI;
- •10. Subject has a mixed Gram-positive PJI other than staphylococci;
- •11. Cultures positive for staphylococci that have a non-susceptible MIC to daptomycin, vancomycin or teicoplanin;
- •12. Subject has a fungal or mycobacterial PJI;
- •13. Subject is known to be HIV-infected with CD4 count =200 cells/ mm3;
- •14. Subject has an abnormal CPK (elevated CPK level =2 x ULN) at baseline as measured by central laboratory;
- •15. Subject is currently under treatment with chemotherapeutic agents, excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer);
- •16. Subject is severely neutropenic (absolute neutrophil count <0.500x103/µL);
- •17. Subject has been previously enrolled in the study;
- •18. Subject has a documented history of significant allergy or intolerance to daptomycin, vancomycin, teicoplanin, or semi-synthetic penicillins;
- •19. Subject has pneumonia;
- •20. Subject has prior exposure to daptomycin (either investigational or commercial) within the past 30 days;
- •21. Subject is currently receiving another investigational drug;
- •22. Subject is pregnant, nursing, or lactating;
- •23. Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study. Corticosteroids at doses greater than 10 mg daily for longer than 8 weeks duration will be considered immunosuppressive.
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