Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
关键词
抽象
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.
日期
最后验证: | 11/30/2019 |
首次提交: | 12/02/2019 |
提交的预估入学人数: | 12/02/2019 |
首次发布: | 12/04/2019 |
上次提交的更新: | 12/04/2019 |
最近更新发布: | 12/05/2019 |
实际学习开始日期: | 02/28/2019 |
预计主要完成日期: | 07/30/2019 |
预计完成日期: | 07/30/2019 |
状况或疾病
干预/治疗
Drug: Group I
Drug: Group II
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Group I Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic | Drug: Group I Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly) |
Experimental: Group II Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic | Drug: Group II Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly) |
资格标准
有资格学习的年龄 | 1 Year 至 1 Year |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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 Exclusion Criteria: - patients with a history of penicillin or cephalosporin allergy - patients with kidney dysfunction |
结果
主要结果指标
1. Temperature decrease [after 72 hours of antibiotic adminstration]
2. Increase of Absolute Neutrophil Count [after 72 hours of antibiotic administration]