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Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

Primary Purpose

Neutropenia, Febrile, Leukemia, Pediatric Cancer

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Ceftazidime Injection
Cefepime Injection
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia, Febrile focused on measuring fever, neutropenia, temperature, absolute neutrophil count, antibiotic

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

Temperature decrease
Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
Increase of Absolute Neutrophil Count
ANC >= 1000

Secondary Outcome Measures

Full Information

First Posted
December 3, 2019
Last Updated
December 5, 2019
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04187755
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Febrile, Leukemia, Pediatric Cancer, Antibiotic Reaction
Keywords
fever, neutropenia, temperature, absolute neutrophil count, antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Participants were given ceftazidime as the antibiotic therapy with standard regimens and dose of antibiotic
Arm Title
Group II
Arm Type
Experimental
Arm Description
Participants were given cefepime as the antibiotic therapy with standard regimens and dose of antibiotic
Intervention Type
Drug
Intervention Name(s)
Ceftazidime Injection
Intervention Description
Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)
Intervention Type
Drug
Intervention Name(s)
Cefepime Injection
Intervention Description
Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)
Primary Outcome Measure Information:
Title
Temperature decrease
Description
Decrease of temperature <= 37,5 degree celsius after administration of antibiotic
Time Frame
after 72 hours of antibiotic adminstration
Title
Increase of Absolute Neutrophil Count
Description
ANC >= 1000
Time Frame
after 72 hours of antibiotic administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murti A MD,PhD
Organizational Affiliation
Indonesia University
Official's Role
Study Director
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

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