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

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.

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.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Indonesia

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Sponsors and Collaborators

Indonesia University

Investigators

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

More Information

• Responsible Party: Murti Andriastuti, Doctor, Doctor, Study director, Indonesia University
• ClinicalTrials.gov Identifier: NCT04187755
• Other Study ID Numbers: CefepimevsCeftazidime
• First Posted: December 5, 2019
• Last Update Posted: December 6, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Leukemia; Neutropenia; Febrile Neutropenia; Neoplasms by Histologic Type; Neoplasms; Agranulocytosis; Leukopenia; Leukocyte Disorders; Hematologic Diseases; Ceftazidime; Cefepime; Anti-Bacterial Agents; Anti-Infective Agents