A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 624
- 试验地点
- 84
- 主要终点
- Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms
研究概览
简要总结
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether levofloxacin given prophylactically during periods of neutropenia to patients being treated with chemotherapy for acute leukemia (AL) or undergoing hematopoietic stem cell transplantation (HSCT) will decrease the incidence of bacteremia.
SECONDARY OBJECTIVES:
I. To determine the effect of prophylactic levofloxacin on resistance patterns of bacterial isolates from all sterile site cultures, and the evolution of antimicrobial resistance from peri-rectal swab isolates of Enterobacteriaceae, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Streptococcus mitis.
II. To determine the effect of levofloxacin prophylaxis on total number of days of antibiotic administration (prophylactic, empiric, and treatment) in children undergoing therapy for AL or HSCT.
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
- Single
入排标准
- 年龄范围
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must fit 1 of the following 2 categories:
- •Chemotherapy patients
- •Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either:
- •De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy
- •Relapsed acute lymphoblastic leukemia (ALL)
- •For the purposes of this study, "intensive chemotherapy" is defined as regimens that are predicted by the local investigator to cause neutropenia for > 7 days; examples include, but are not limited to, treatment with "4-drug induction" (anthracycline, vincristine, asparaginase, and steroid), high dose cytarabine, anthracycline/cytarabine, ifosfamide/etoposide, and clofarabine-containing regimens
- •Stem cell transplantation patients
- •Planned to receive at least 1 myeloablative autologous or allogeneic HSCT
- •For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days
- •Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender as follows:
- •0.5 mg/dL (6 months to < 1 year of age)
- •0.6 mg/dL (1 to < 2 years of age)
- •0.8 mg/dL (2 to < 6 years of age)
- •1.0 mg/dL (6 to < 10 years of age)
- •1.2 mg/dL (10 to < 13 years of age)
- •1.5 mg/dL (male)/1.4 mg/dL (female) (13 to < 16 years of age)
- •1.7 mg/dL (male)/1.4 mg/dL (female) (>= 16 years of age)
- •Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Patients previously enrolled on the trial are not eligible; therefore, patients with AL who were on study during intensive chemotherapy are not eligible to be enrolled during the HSCT
- •Patients with an allergy to quinolones
- •Patients with chronic active arthritis
- •Patients with a known pathologic prolongation of the corrected QT (QTc)
- •Females who are pregnant or breast feeding
- •Patients being treated with antibacterial agents, other than any of the following:
- •Cotrimoxazole or other agents including dapsone, atovaquone, and pentamidine administered for Pneumocystitis jiroveci (PCP) prophylaxis
- •Topical antibiotics
- •Central venous catheter antibiotic lock therapy
- •Note: prophylactic antifungal therapy is NOT an exclusion criterion
- •Patients currently enrolled on the ACCL1034 study are not eligible until they have completed the 90 day observation period of that study
研究组 & 干预措施
Arm I (levofloxacin)
Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover.
干预措施: levofloxacin (Drug)
结局指标
主要结局
Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms
时间窗: Up to 60 days after enrollment or receiving levofloxacin
A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.
次要结局
- Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms(Up to 60 days after enrollment or receiving levofloxacin)
- Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms(Up to 60 days after enrollment or receiving levofloxacin)
- Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms(Up to 60 days after enrollment or receiving levofloxacin)
- Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms(Up to 60 days after enrollment or receiving levofloxacin)
- Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms(Enrollment, 2 months and 12 months post infection observation period)
- Comparison of the Percentage of Patients Having Severe Infection Between Arms(Up to 60 days after enrollment or receiving levofloxacin)