Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Neutropenic Fever, Non Hodgkin Lymphoma
Conditions
Keywords
ciprofloxacin, ceftazidime, neutropenic fever, Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Non Hodgkin Lymphoma
Brief summary
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.
Detailed description
Furthermore, this clinical trial aims to: 1. Compare the efficacy of empirical antibiotic administration of Ciprofloxacin and Ceftazidime in pediatric malignancy patients with high-risk neutropenic fever. 2. Analyze the differences in clinical effectiveness between ceftazidime and ciprofloxacin antibiotics based on the duration of fever, duration of neutropenia, duration of hospitalization in high-risk neutropenic fever in children with hematological malignancies. 3. Compare the mortality of pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin. 4. Compare antibiotic escalation decisions in pediatric patients with high-risk neutropenic fever due to hematological malignancies who received empirical antibiotic therapy of ceftazidime and ciprofloxacin.
Interventions
DRUGCeftazidime
Ceftazidime 150 mg/kgBW/24 hours divided into 3 doses.
DRUGCiprofloxacin
Ciprofloxacin 10 mg/kgBW/12 hours
Sponsors
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Neutropenia | From first antibiotic administration to 48 hours after administration | The length of time the subject experiences neutropenia, absolute neutrophil count is \<500 |
| Duration of fever | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | 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. |
| Duration of antibiotic use | days from first administration to the last intravenous antibiotic administration | days of antibiotic use from the first administration to the last intravenous antibiotic administration |
| Antibiotic escalation decisions | From first administration of Ciprofloxacin or Ceftazidime to 48 hours after administration | Clinician decisions in escalating empirical antibiotics to second-line antibiotics |
| Mortality | from first administration of ciprofloxacin or ceftazidime to 30 days after recruitment | Mortality of subject in admission is proven by a death certificate |
Countries
Indonesia
Contacts
Primary Contactdr. Khairunisa Rahma Handayani, Medical doctor
Outcome results
None listed