Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT04187755

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neutropenia, Febrile Leukemia Pediatric Cancer Antibiotic Reaction	Drug: Ceftazidime Injection Drug: Cefepime Injection	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

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.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)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic	Drug: Ceftazidime Injection 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: Cefepime Injection Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)

Arm

Intervention/Treatment

Active Comparator: Group I

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

Drug: Ceftazidime Injection

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: Cefepime Injection

Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)

Outcome Measures

Primary Outcome Measures

Temperature decrease [after 72 hours of antibiotic adminstration]
Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
Increase of Absolute Neutrophil Count [after 72 hours of antibiotic administration]
ANC >= 1000

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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