Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies

NCT07016165 | Recruiting Phase 4

• 1 other identifier: KE/FK/0517/EC/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies

• Collecting patient history, conducting physical exams, and performing supporting tests.
• Randomly assigning participants into two groups: one group will receive the standard treatment with intravenous ciprofloxacin, while the other group will receive the intervention treatment with intravenous ceftazidime.
• Both groups will be monitored for various outcomes, including the length of fever, length of low white blood cell count, length of hospital stay, length of antibiotic use, any changes in antibiotics, and mortality.

Conditions

Neutropenic Fever; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Non Hodgkin Lymphoma

Keywords

ciprofloxacin; ceftazidime; neutropenic fever; Acute Lymphoblastic Leukemia; Acute Myeloblastic Leukemia; Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Duration of fever

  Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record

  from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free

• Duration of Neutropenia

  The length of time the subject experiences neutropenia, absolute neutrophil count is \<500

  From first antibiotic administration to 48 hours after administration

Secondary Outcomes (4)

• Duration of hospitalization

  From first administration of Ciprofloxacin or Ceftazidime to hospital discharge

• Duration of antibiotic use

  days from first administration to the last intravenous antibiotic administration

• Antibiotic escalation decisions

  From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration

• Mortality

  from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment

Study Arms (2)

Group A

ACTIVE COMPARATOR

Standard therapy IV ciprofloxacin 10 mg/kgBW/12 hours

Drug: Ciprofloxacin

Group B

EXPERIMENTAL

IV ceftazidime 150 mg/kgBW/24 hours divided into 3 doses

Drug: Ceftazidime

Interventions

Ceftazidime DRUG

Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.

Group B

Ciprofloxacin DRUG

Ciprofloxacin 10 mg/kgBW/12 hours

Group A

Eligibility Criteria

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

You may qualify if:

• Children aged 0 to 18 years with hematological malignancies.
• Children with high-risk neutropenic fever, namely children with blood malignancies induction phase ALL, consolidation phase ALL, reinduction phase ALL, relapse ALL; meningeal ALL, AML, and NHL, diagnosed by a competent pediatrician on duty.
• Consent from parents to be included in the study.

You may not qualify if:

• Children with malignancies but accompanied by comorbidities (HIV infection, septic shock).
• Allergy to ciproloxacin or ceftazidime.
• Fever associated with blood transfusion reactions.
• Receiving other antibiotics since 72 hours before being included in the study, except for cotrimoxazole prophylaxis for the prevention of Pneumocystis carinii pneumonia, and ciproloxacin prophylaxis in AML.
• Children with blood malignancies who have impaired renal function (serum creatinine ≥ 1.5 times the upper normal limit) and impaired liver function (SGPT \> 5 times the upper normal limit).

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

RSUP dr Sardjito

Sleman, DI Yogyakarta, Indonesia

RECRUITING

Related Publications (3)

• Corapcioglu F, Sarper N. Cefepime versus ceftazidime + amikacin as empirical therapy for febrile neutropenia in children with cancer: a prospective randomized trial of the treatment efficacy and cost. Pediatr Hematol Oncol. 2005 Jan-Feb;22(1):59-70. doi: 10.1080/08880010590896297.

  PMID: 15770833 BACKGROUND

• Kamonrattana R, Sathitsamitphong L, Choeyprasert W, Charoenkwan P, Natesirinilkul R, Fanhchaksai K. A Randomized, Open-Labeled, Prospective Controlled Study to Assess the Efficacy of Frontline Empirical Intravenous Piperacillin/Tazobactam Monotherapy in Comparison with Ceftazidime Plus Amikacin for Febrile Neutropenia in Pediatric Oncology Patients. Asian Pac J Cancer Prev. 2019 Sep 1;20(9):2733-2737. doi: 10.31557/APJCP.2019.20.9.2733.

  PMID: 31554370 BACKGROUND

• Yasuda T, Suzuki R, Ishikawa Y, Terakura S, Inamoto Y, Yanada M, Nagai H, Ozawa Y, Ozeki K, Atsuta Y, Emi N, Naoe T. Randomized controlled trial comparing ciprofloxacin and cefepime in febrile neutropenic patients with hematological malignancies. Int J Infect Dis. 2013 Jun;17(6):e385-90. doi: 10.1016/j.ijid.2012.12.005. Epub 2013 Jan 11.

  PMID: 23317527 BACKGROUND

MeSH Terms

Conditions

Febrile Neutropenia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin

Interventions

Ceftazidime; Ciprofloxacin

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Lymphoma

Intervention Hierarchy (Ancestors)

Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Central Study Contacts

dr. Khairunisa Rahma Handayani, Medical doctor

CONTACT

+6281246572652; khairunisarahma99@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Pediatric Hematolo-Oncology Divison

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-06

Locations

ID (1)