An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Arrevus Inc.
- 入组人数
- 30
- 主要终点
- Clinical Success at 6 Months
研究概览
简要总结
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
详细描述
Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents between 12 and 18 years must weigh >60 kg
- •Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
- •Not a candidate, as determined by the Investigator, for suitable alternative therapy
- •After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment
排除标准
- •Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
- •Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation)
- •Evidence of significant liver disease: ALT >3 × ULN or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
研究组 & 干预措施
CEM-102 (Sodium fusidate)
1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:
- 6 months of treatment; or
- 24 months of treatment (if continued on chronic suppressive therapy)
干预措施: sodium fusidate (Drug)
结局指标
主要结局
Clinical Success at 6 Months
时间窗: 6 months after start of treatment
Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia
次要结局
- Safety and Tolerability(Entire study period - up to 24 months)
- Clinical Success at 9 Months(9 months after start of treatment)
- Clinical Success at 12 Months(12 months after start of treatment)
- Clinical Success at 15 Months(15 months after start of treatment)
- Clinical Success at 18 Months(18 months after start of treatment)
- Clinical Success at 21 Months(21 months after start of treatment)
- Clinical Success at 24 Months(24 months after start of treatment)