Double-blind, Randomized, Mono-center, Placebo-controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Incidence of Clinically Significant Bacteremia
研究概览
简要总结
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.
Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.
详细描述
Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-dose chemotherapy followed by peripheral autologous stem cell transplantation
- •Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor
排除标准
- •Allogenic stem cell transplantation
- •Aplastic anemia
- •Antibiotic treatment within seven days prior to randomization
- •Signs and symptoms of current infection
研究组 & 干预措施
Moxifloxacin
moxifloxacin 400 mg tablets once daily
干预措施: moxifloxacin (Drug)
Placebo
identical appearing placebo
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of Clinically Significant Bacteremia
时间窗: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.
次要结局
- Overall Survival(follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation))
- Time to Occurrence of Fever >= 38°C(end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm))
- Reason for Discontinuation of Treatment(end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm))
- Type of Isolates and Infections(end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm))
- Type of Infection(follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation))
研究者
Oliver Cornely, MD
Medical Director of the Center of Clinical Trials (ZKS)
University of Cologne