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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

Tracking Information
First Submitted Date  ICMJE December 3, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
  • Temperature decrease [ Time Frame: after 72 hours of antibiotic adminstration ]
    Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
  • Increase of Absolute Neutrophil Count [ Time Frame: after 72 hours of antibiotic administration ]
    ANC >= 1000
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Temperature decrease [ Time Frame: after 72 hours of antibiotic adminstration ]
    Decrease of temperature <= 37,5 degree celcius after administration of antibiotic
  • Increase of Absolute Neutrophil Count [ Time Frame: after 72 hours of antibiotic administration ]
    ANC >= 1000
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
Official Title  ICMJE Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever in Pediatric Acute Leukemia: Review of Temperature and Absolute Neutrophil
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Neutropenia, Febrile
  • Leukemia
  • Pediatric Cancer
  • Antibiotic Reaction
Intervention  ICMJE
  • Drug: Ceftazidime Injection
    Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)
  • Drug: Cefepime Injection
    Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)
Study Arms  ICMJE
  • Active Comparator: Group I
    Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic
    Intervention: Drug: Ceftazidime Injection
  • Experimental: Group II
    Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic
    Intervention: Drug: Cefepime Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2019)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04187755
Other Study ID Numbers  ICMJE CefepimevsCeftazidime
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Murti Andriastuti, Doctor, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Murti A MD,PhD Indonesia University
PRS Account Indonesia University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP