Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase

ConditionsNeutropenic Fever Acute Lymphoblastic Leukemia

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age6-18

SponsorGadjah Mada University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Levofloxacin
Drug
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)
Placebo
Other intervention
Receiving oral placebo at the same dosage as the treatment group.

Treatment groups

124 Participants

are divided into 2 treatment groups

Group A: Group A: LevofloxacinExperimental treatment 1 intervention

Group B: Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Median time to first febrile neutropenia

The number of participants with first febrile neutropenia and the median day of occurrence.

Time frame

First febrile neutropenia up to day 63

Clinical Outcome

The number of participants who experienced fever, first febrile neutropenia, severe infection, organ-related infection, microbiologically confirmed infection, infection-related mortality

Time frame

First febrile neutropenia up to day 63

Secondary outcomes

Caused of mortality

The cause of mortality in the participants.

Time frame

up to 12 weeks

Patients with positive cultures

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).

Time frame

up to 12 weeks

Other outcomes

Baseline characteristics of the study groups

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

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gadjah Mada University

Lead sponsor

Dr. Sardjito Hospital, Yogyakarta

Collaborator

Source ClinicalTrials.gov

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