Clinical trial NCT04187755: Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
Official title: Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever in Pediatric Acute Leukemia: Review of Temperature and Absolute Neutrophil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neutropenia, Febrile
Leukemia
Pediatric Cancer
Antibiotic Reaction
Keywords: fever
neutropenia
temperature
absolute neutrophil count
antibiotic
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Temperature decrease
timeFrame: after 72 hours of antibiotic adminstration
measure: Increase of Absolute Neutrophil Count
timeFrame: after 72 hours of antibiotic administration
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Murti A MD,PhD
role: STUDY_DIRECTOR
References: