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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Beta-lactam Plus Levofloxacin to Enhance Therapy in Streptococcal Septicemia

NCT07240077

Bacteremia Streptococcus Infection

NOT_YET_RECRUITING PHASE4

A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting

NCT00034736

Pneumonia

COMPLETED PHASE3

Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

NCT00035347

Community-Acquired Pneumonia (CAP)

COMPLETED PHASE4

A Study of Incidence of Musculoskeletal Disorders in Children Who Have Received Levofloxacin or a Standard Non-Fluoroquinolone Therapy for Acute Bacterial Infection

NCT00210639

Musculoskeletal Diseases

COMPLETED

Antibiotic Stewardship in Suspected Neutropenic Fever (ASTERIC Trial)

NCT06794320

Neutropenic Fever

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neutropenic Fever Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: Levofloxacin

Receiving oral levofloxacin as infection prophylaxis during the induction phase, with the following dosage:

* Age \< 5 years: 10 mg/kg PO every 12 hours (maximum 250 mg/dose)
* Age ≥ 5 years: 10 mg/kg PO once daily (maximum 500 mg/day)

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type 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)

Group B: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levofloxacin

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)

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No