Acute Lymphoblastic Leukemia, Neutropenic Fever
Conditions
Keywords
Neutropenic Fever, Acute Lymphoblastic Leukemia, Levofloxacin
Brief summary
The goal of this clinical trial is To evaluate the benefit of levofloxacin prophylaxis in prolonging the median time to first febrile neutropenia in pediatric ALL patients during induction phase. It will also learn about the safety of levofloxacin during induction treatment. The main questions it aims to answer are: * Does levofloxacin prophylaxis increase the median time to the first febrile neutropenia episode compared to placebo? * What are the rates of fever, severe infection, organ-related bacterial infection, and mortality in children receiving levofloxacin compared to placebo? Researchers will compare oral levofloxacin to a placebo (a look-alike substance with no active drug) to see if levofloxacin is effective in preventing infection during induction chemotherapy. Participants will: * Be children aged 1 to 18 years with ALL undergoing induction chemotherapy. * Be randomly assigned to receive either levofloxacin prophylaxis or placebo during the induction phase. * Have regular checkups, physical exams, and laboratory tests during induction. * Be monitored for fever, febrile neutropenia, severe infections, bacterial infections, and mortality. * Stop prophylaxis once the first febrile neutropenia occurs or induction therapy is completed.
Detailed description
Furthermore, this clinical trial aims to: * To determine the incidence of fever during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the incidence of febrile neutropenia during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the incidence of severe infections during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the number of organ-related bacterial infections, whether microbiologically confirmed or not, during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo. * To determine the mortality rate during the induction phase in pediatric ALL patients receiving levofloxacin prophylaxis compared with placebo.
Interventions
DRUGLevofloxacin
younger than 5 years received levofloxacin 10 mg/kg by mouth every 12 hours and patients 5 years and older received 10 mg/kg by mouth once daily (maximum 500 mg/dose)
OTHERPlacebo
Receiving oral placebo at the same dosage as the treatment group.
Sponsors
Dr. Sardjito Hospital, Yogyakarta
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* All patients aged 1 to 18 years diagnosed with acute lymphoblastic leukemia (ALL). * Receiving induction phase 1A chemotherapy for ALL using the Indonesian National Childhood ALL Pilot Protocol 2024 Standard Risk; induction phases 1A and 1B chemotherapy using the Indonesian National Childhood ALL Pilot Protocol 2024 High Risk; or induction chemotherapy using the ACT4ALL Protocol 2025 at Dr. Sardjito Hospital. * No history of allergy to levofloxacin. * Parents/guardians provide written informed consent.
Exclusion criteria
* Death before initiation of chemotherapy. * Patients with clinically or microbiologically confirmed infection within 72 hours prior to induction chemotherapy who require antibiotics for more than 5 days (to avoid antibiotic therapy as a confounding factor for antibiotic prophylaxis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median time to first febrile neutropenia | First febrile neutropenia up to day 63 | The number of participants with first febrile neutropenia and the median day of occurrence. |
| Clinical Outcome | First febrile neutropenia up to day 63 | The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caused of mortality | up to 12 weeks | The cause of mortality in the participants. |
| Patients with positive cultures | up to 12 weeks | The number of participants who were positive for bacteria or fungi, and the number of participants with antibiotic resistance (resistant to fluoroquinolones, carbapenems, or vancomycin). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline characteristics of the study groups | Day 1 | Number of participants with each variable: Age (only 2 variations) * \<10 years * ≥10 years Sex * Male * Female Nutritional Status Categories of Children Aged ≤ 10 Years Based on WHO BMI-for-Age Z-scores (BMI in kg/m\^2) * Severely wasted * Wasted * Normal * Possible risk of overweight * Overweight * Obese BMI Classification for Children Aged \> 10 Years Based on BMI (kg/m\^2) * Underweight * Normal * Overweight * Obesity Leukemia risk group (only 2 variation, using the Indonesia Pilot Protocol 2024) * Standard risk * High risk |
Countries
Indonesia
Contacts
Primary Contactdr. Regina Amanda Putri, M.D
Backup Contactdr. Idha Yulandari, Sp.A, Fellow
Outcome results
None listed