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Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

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ClinicalTrials.gov Identifier: NCT04187755
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Murti Andriastuti, Doctor, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : March 1, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019


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)




Primary Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187755


Locations
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Indonesia
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Sponsors and Collaborators
Indonesia University
Investigators
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Study Director: Murti A MD,PhD Indonesia University
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Responsible Party: Murti Andriastuti, Doctor, Doctor, Study director, Indonesia University
ClinicalTrials.gov Identifier: NCT04187755    
Other Study ID Numbers: CefepimevsCeftazidime
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murti Andriastuti, Doctor, Indonesia University:
fever
neutropenia
temperature
absolute neutrophil count
antibiotic
Additional relevant MeSH terms:
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Leukemia
Neutropenia
Febrile Neutropenia
Neoplasms by Histologic Type
Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Ceftazidime
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents