RSUP dr Sardjito
Sleman, DI Yogyakarta, Indonesia
Location status: Recruiting
NCT Number: NCT07016165
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Interventional
Phase 4
Sleman, DI Yogyakarta, Indonesia
Location status: Recruiting
Furthermore, this clinical trial aims to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
Ciprofloxacin 10 mg/kgBW/12 hours
Time frame: from first administration of Ciprofloxacin or Ceftazidime to 48 hours fever free
Duration of fever since receiving the first antibiotic, based on the temperature graph available in the electronic medical record
Time frame: From first antibiotic administration to 48 hours after administration
The length of time the subject experiences neutropenia, absolute neutrophil count is <500
Time frame: From first administration of Ciprofloxacin or Ceftazidime to hospital discharge
The duration from the date of subject recruitment to the date of hospital discharge, as recorded in the electronic medical record.
Time frame: days from first administration to the last intravenous antibiotic administration
days of antibiotic use from the first administration to the last intravenous antibiotic administration
Time frame: From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration
Clinician decisions in escalating empirical antibiotics to second-line antibiotics
Time frame: from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment
Mortality of subject in admission is proven by a death certificate
Contact information is provided by the study sponsor or research team.
Gadjah Mada University
Other
Ciprofloxacin Versus Ceftazidime as Empirical Therapy of High-Risk Neutropenic Fever in Children With Hematologic Malignancies : A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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