Cefepime vs Ceftazidime as Empirical Therapy for Neutropenic Fever

NCT04187755 | Completed Phase 4 DMC

• 1 other identifier: CefepimevsCeftazidime
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia, Febrile; Leukemia; Pediatric Cancer; Antibiotic Reaction

Keywords

fever; neutropenia; temperature; absolute neutrophil count; antibiotic

Outcome Measures

Primary Outcomes (2)

• Temperature decrease

  Decrease of temperature \<= 37,5 degree celsius after administration of antibiotic

  after 72 hours of antibiotic adminstration

• Increase of Absolute Neutrophil Count

  ANC \>= 1000

  after 72 hours of antibiotic administration

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Drug: Ceftazidime Injection

Group II

EXPERIMENTAL

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

Drug: Cefepime Injection

Interventions

Ceftazidime Injection DRUG

Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)

Group I

Cefepime Injection DRUG

Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)

Group II

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patients with a history of penicillin or cephalosporin allergy
• patients with kidney dysfunction

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Febrile Neutropenia; Leukemia; Neoplasms; Fever; Neutropenia

Interventions

Ceftazidime; Cefepime

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Histologic Type; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Murti A MD,PhD

  Indonesia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Study director

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: March 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

ID (1)