Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Phase 4

Completed

• Conditions: Leukemia; Antibiotic Reaction; Neutropenia, Febrile; Pediatric Cancer
• Interventions: Drug: Ceftazidime Injection; Drug: Cefepime Injection

• Registration Number: NCT04187755
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Ceftazidime Injection	Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic
Group II	Cefepime Injection	Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia