Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187755
• Other study ID #: CefepimevsCeftazidime
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Reaction
• Febrile Neutropenia
• Leukemia
• Neutropenia
• Neutropenia, Febrile
• Pediatric Cancer

Intervention

Drug:
• Ceftazidime Injection
Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)
• Cefepime Injection
Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature decrease	Decrease of temperature <= 37,5 degree celsius after administration of antibiotic	after 72 hours of antibiotic adminstration
Primary	Increase of Absolute Neutrophil Count	ANC >= 1000	after 72 hours of antibiotic administration