Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
Condition: Neutropenia, Febrile; Leukemia; Pediatric Cancer; Antibiotic Reaction
MeSH terms: Leukemia; Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ceftazidime Injection; Cefepime Injection
Intervention type(s): Drug; Drug
Intervention description(s): Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly); Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)
Intervention MeSH terms: Ceftazidime; Cefepime
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly divided into two intervention groups, ceftazidime and cefepime, each group consist of 36 patients. Patients were treated, the results were noted after 72 hours.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fever; neutropenia; temperature; absolute neutrophil count; antibiotic