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Completed

NCT Number: NCT04187755

Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftazidime Injection

Drug

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

Cefepime Injection

Drug

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

Primary outcomes

  1. Temperature decrease

    Time frame: after 72 hours of antibiotic adminstration

    Decrease of temperature <= 37,5 degree celsius after administration of antibiotic

  2. Increase of Absolute Neutrophil Count

    Time frame: after 72 hours of antibiotic administration

    ANC >= 1000

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2019
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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