Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 212
- 试验地点
- 45
- 主要终点
- Proportion of Patients Experiencing a Serious Bacterial Infection
研究概览
简要总结
RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy.
PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.
详细描述
OBJECTIVES:
- Evaluate whether oral antibiotic prophylaxis with co-trimoxazole (TMP-SMX) versus ciprofloxacin (CPFX) or ofloxacin versus no prophylaxis will significantly reduce rates of serious bacterial infections during the first 3 months of chemotherapy in patients with multiple myeloma.
- Determine whether antibiotic prophylaxis with TMP-SMX or CPFX (or ofloxacin) is associated with an increased incidence of nonbacterial infection or an increased rate of infection from organisms resistant to prophylactic antibiotics.
- Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects.
- Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center. Patients are randomized to 1 of 2treatment arms.
- Arm I: Patients receive co-trimoxazole every 12 hours for 2 months followed by observation for 2 months.
- Arm II: Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months followed by observation for 1 month.
- Arm III: The patient will receive no prophylaxis.
Patients continue their randomly assigned treatment throughout any infection in addition to any treatment needed for infection. Patients also remain on their randomly assigned treatment if chemotherapy is discontinued, changed, or delayed during the 3 month study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ciprofloxacin or ofloxacin
Quinolone:
Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
干预措施: ciprofloxacin (Drug)
Ciprofloxacin or ofloxacin
Quinolone:
Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
干预措施: ofloxacin (Drug)
TMP-SMX
TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
干预措施: 160 mg trimethoprim and 800 mg sulfamethoxazole (Drug)
结局指标
主要结局
Proportion of Patients Experiencing a Serious Bacterial Infection
时间窗: First three months of chemotherapy
This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.
次要结局
未报告次要终点
研究者
Gary Morrow
Director, UR NCORP Research BAase
University of Rochester NCORP Research Base