Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

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

Tracking Information

• First Submitted Date: December 3, 2019
• First Posted Date: December 5, 2019
• Last Update Posted Date: December 6, 2019
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever
• Official Title: 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: Interventional
• Study Phase: Phase 4

Study Design

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

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

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 3, 2019): 72
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 31, 2019
• Actual Primary Completion Date: July 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04187755
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Murti Andriastuti, Doctor, Indonesia University
• Study Sponsor: Indonesia University
• Collaborators: Not Provided

Investigators

• Study Director: Murti A MD,PhD; Indonesia University

• PRS Account: Indonesia University
• Verification Date: December 2019