Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Neutropenia, Febrile Leukemia Pediatric Cancer Antibiotic Reaction

Keywords

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fever neutropenia temperature absolute neutrophil count antibiotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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

Study Groups

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Group I

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

Group Type ACTIVE_COMPARATOR

Ceftazidime Injection

Intervention Type DRUG

Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)

Group II

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

Group Type EXPERIMENTAL

Cefepime Injection

Intervention Type DRUG

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

Interventions

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Ceftazidime Injection

Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)

Intervention Type DRUG

Cefepime Injection

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Murti Andriastuti, Doctor

Doctor, Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murti A MD,PhD

Role: STUDY_DIRECTOR

Indonesia University

Locations

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Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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