Actively Recruiting

Phase 4
Age: 0 - 18Years
All Genders
NCT07016165

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

Led by Gadjah Mada University · Updated on 2025-08-22

120

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical trial will compare use of ciprofloxacin and ceftazidime work in treating high-risk fever in children with hematological malignancies 1. Does ceftazidime work better than ciprofloxacin as a first-choice antibiotic for children with hematological malignancies who have high-risk fever from low neutrophil count? 2. Are there any specific factors that affect how children with hematological malignancies respond to ciprofloxacin or ceftazidime when treating high-risk fever? Participants in this study are children with hematological malignancies who have a high risk of fever due to low neutrophil count. Children, aged 0 to 18 years old, will be hospitalized between June and December 2025 at Sardjito General Hospital The study will involve: * 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

Official Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 0 to 18 years with hematological malignancies
  • Children with high-risk neutropenic fever diagnosed by a pediatrician, including various phases of ALL, AML, and NHL
  • Consent from parents to participate in the study
Not Eligible

You will not qualify if you...

  • Children with malignancies having comorbidities such as HIV infection or septic shock
  • Allergy to ciprofloxacin or ceftazidime
  • Fever caused by blood transfusion reactions
  • Receiving other antibiotics within 72 hours before study entry, except cotrimoxazole or ciprofloxacin prophylaxis
  • Impaired kidney function (serum creatinine ≥ 1.5 times upper normal limit) or liver function (SGPT > 5 times upper normal limit)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

RSUP dr Sardjito

Sleman, DI Yogyakarta, Indonesia

Actively Recruiting

Loading map...

Research Team

D

dr. Khairunisa Rahma Handayani, Medical doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here