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临床试验/NCT04187755
NCT04187755已完成4 期

Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever in Pediatric Acute Leukemia: Review of Temperature and Absolute Neutrophil

Indonesia University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
72
试验地点
1
主要终点
Increase of Absolute Neutrophil Count

研究概览

简要总结

Empirical antibiotic therapy has been known to reduce the mortality and morbidity rate in neutropenic fever. Until now, ceftazidime was the first line choice of neutropenic fever. However, resistance against ceftazidime has been reported. Several countries have reported cefepime in reducing fever and shorten the length of hospitalization better than ceftazidime. This study is aimed to compare the effectivity of ceftazidime and cefepime to reduce fever and to increase the absolute neutrophils count (ANC) in the first 72 hours.

详细描述

This study is a randomized controlled trial with single blinding, conducted in the children's hematology-oncology wards of Cipto Mangunkusumo Hospital and Harapan Kita Children's Hospital in Jakarta, December 2018 through May 2019. Study population includes all children with leukemia with febrile neutropenia episodes that are being hospitalized in our hospitals in the appropriate time. Subjects were chosen by consecutive sampling. Inclusion criteria includes children with leukemia aged 1 month to 18 years old undergoing chemotherapy, having fever of ≥ 38,3 degree celsius in axillar temperature with ANC < 1000/mm3. Patients' parents or guardians must be willing to participate and willing to sign a written informed consent form. Exclusion criteria includes patients with a history of penicillin or cephalosporin allergy and/or patients with kidney dysfunction. Block randomization was done to place each patient into cefepime or ceftazidime group. Data analysis was done using SPSS ver. 21 software. Numerical data was shown as mean with standard deviation if the data is normally distributed or median with minimum-maximum value if the data is not normally distributed. Chi-square as the correlation test was done in order to determine the association between free and dependent variables, based on nominal data. Mann Whitney test was done as the correlation test in order to test the difference between medians of uncoupled groups and one categorical variable, and one interval variable and the not normally distributed data.

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
Single (Investigator)

盲法说明

This study is a randomized controlled trial with single blinding, participants were assigned into ceftazidime and cefepime group. Investigator did not know the randomization done by the other party

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children with leukemia aged 1 month to 18 years old undergoing chemotherapy
  • having fever of ≥ 38,3 0C in axillar temperature
  • ANC < 1000/mm3
  • patients' parents or guardians must be willing to participate and willing to sign a written informed consent form

排除标准

  • patients with a history of penicillin or cephalosporin allergy
  • patients with kidney dysfunction

研究组 & 干预措施

Group I

Active Comparator

Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic

干预措施: Ceftazidime Injection (Drug)

Group II

Experimental

Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic

干预措施: Cefepime Injection (Drug)

结局指标

主要结局

Increase of Absolute Neutrophil Count

时间窗: after 72 hours of antibiotic administration

ANC \>= 1000

Temperature decrease

时间窗: after 72 hours of antibiotic adminstration

Decrease of temperature \<= 37,5 degree celsius after administration of antibiotic

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murti Andriastuti, Doctor

Doctor, Study director

Indonesia University

研究点 (1)

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