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临床试验/JPRN-C000000083
JPRN-C000000083已完成3 期

Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study) - RCT comparing CPFX and CFPM in febrile neutropenic patients with hematologic diseases (C-SHOT 0402 study)

Center for Supporting Hematology-Oncology Trials (C-SHOT)0 个研究点目标入组 200 人开始时间: 2005年8月29日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
200

研究概览

简要总结

Fifty-one episodes were included in this trial, and 49 episodes (CPFX vs. CFPM: 24 vs. 25) were evaluated. Treatment efficacy at day 7 was significantly higher in the CFPM group (successful clinical response: nine with CPFX and 19 with CFPM; p=0.007). The response was better in high-risk patients with neutrophil counts of less or equal to 100/microliter (p=0.003). The overall response during the study period was similar between the CPFX and CFPM groups (p=0.64). Adverse events were minimal, and all patients could continue the treatment.

研究设计

研究类型
Interventional

入排标准

年龄范围
15years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • (1) Past history of allergic reaction to the study drug (2) Positive for HIV antibody (3) Pregnant or lactating woman (4) Family history of auditory disturbance (5) Having received systemic antibacterial therapy within 14 days (6) Receiving systemic antifungal or antiviral therapy except fluconazole or acyclovir for cases undergoing transplantation (7) No recovery of neutrophil count of 1,000/microL or higher from the previous febrile episode (8) On treatment with ketoprofen (9) On treatment with sodium valproate (10) Septic shock

研究者

发起方
Center for Supporting Hematology-Oncology Trials (C-SHOT)

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