Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
研究概览
简要总结
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is:
To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities.
This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.
详细描述
Methods:
Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia (<500) APACHE II scores > 20, or significant liver disease will be excluded. All will give written informed consent (Pappas et al. CID. Oct 1, 2007).
Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All agents will be given by slow IV infusion (MFG will be supplied by Astellas).
Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24 h (trough) after the beginning of an infusion (day 3-4).
Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate (if isolated). In addition, recent clinical isolates of C. glabrata will also be tested against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota. AAC. Nov. 2006; Wiederhold. AAC. May 2007).
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
- •Adult patients with presumptive candidemia
排除标准
- •Patients with severe neutropenia (<500)
- •Patients with APACHE II scores > 20
- •Patients with severe liver disease
研究组 & 干预措施
Caspofungin
Patients receive caspofungin 70 mg LD followed by 50 mg qd
干预措施: Caspofungin (Drug)
micafungin 100
Patients receive Micafungin 100 mg qd
干预措施: Micafungin (Drug)
micafungin 200
Patients receive 200 mg Micafungin qd
干预措施: Micafungin (Drug)
结局指标
主要结局
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
时间窗: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M).
次要结局
未报告次要终点
研究者
Gary E. Stein, Pharm.D.
Professor of Medicine
Michigan State University