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NCT Number: NCT07320534

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

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.

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Key information

Conditions

Neutropenic Fever Acute Lymphoblastic Leukemia Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukocyte Disorders Leukopenia Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neutropenia Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Receiving oral placebo at the same dosage as the treatment group.

Primary outcomes

  1. Median time to first febrile neutropenia

    Time frame: First febrile neutropenia up to day 63

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

  2. Clinical Outcome

    Time frame: 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 outcomes

  1. Caused of mortality

    Time frame: up to 12 weeks

    The cause of mortality in the participants.

  2. Patients with positive cultures

    Time frame: 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 outcomes

  1. Baseline characteristics of the study groups

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

dr. Idha Yulandari, Sp.A, Fellow

CONTACT

[email protected]

+6281366659597

dr. Regina Amanda Putri, M.D

CONTACT

[email protected]

+6282322335677

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Collaborators

  • Dr. Sardjito Hospital, Yogyakarta

Registry information

Official study title

The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 8, 2026

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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