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

January 6, 2026 updated by: Idha Yulandari, Gadjah Mada University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • DI Yogyakarta
      • Sleman, DI Yogyakarta, Indonesia
        • RSUP dr Sardjito
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: 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)
Placebo Comparator: Group B: Placebo
Receiving oral placebo at the same dosage as the treatment group.
Other: Placebo
Receiving oral placebo at the same dosage as the treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First febrile neutropenia up to day 63
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
First febrile neutropenia up to day 63

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caused of mortality
Time Frame: up to 12 weeks
The cause of mortality in the participants.
up to 12 weeks
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).
up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Collaborators

Dr. Sardjito Hospital, Yogyakarta

Investigators

  • Principal Investigator: Idha Yulandari, M.D. Pediatric, Gadjah Mada University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

December 25, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE/FK/1504/EC/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Inform Consent Form

IPD Sharing Time Frame

07 October 2025 for 1,5 years

IPD Sharing Access Criteria

No data will be shared publicly. Data access will only be provided to qualified researchers upon justified request and with ethics approval.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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