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

NCT07320534 | Not Yet Recruiting Phase 4

• 1 other identifier: KE/FK/1504/EC/2025
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenic Fever; Acute Lymphoblastic Leukemia

Keywords

Neutropenic Fever; Acute Lymphoblastic Leukemia; Levofloxacin

Outcome Measures

Primary Outcomes (2)

• Median time to first febrile neutropenia

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

  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

  First febrile neutropenia up to day 63

Secondary Outcomes (2)

• Caused of mortality

  up to 12 weeks

• Patients with positive cultures

  up to 12 weeks

Other Outcomes (1)

• Baseline characteristics of the study groups

  Day 1

Study Arms (2)

Group A: Levofloxacin

EXPERIMENTAL

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

Group B: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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)

Group A: Levofloxacin

Placebo OTHER

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

Group B: Placebo

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gadjah Mada University: lead
• Dr. Sardjito Hospital, Yogyakarta: collaborator

Study Sites (1)

RSUP dr Sardjito

Sleman, DI Yogyakarta, Indonesia

Location

Related Publications (2)

• Alexander S, Fisher BT, Gaur AH, Dvorak CC, Villa Luna D, Dang H, Chen L, Green M, Nieder ML, Fisher B, Bailey LC, Wiernikowski J, Sung L; Children's Oncology Group. Effect of Levofloxacin Prophylaxis on Bacteremia in Children With Acute Leukemia or Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2018 Sep 11;320(10):995-1004. doi: 10.1001/jama.2018.12512.

  PMID: 30208456 RESULT

• Patel B, Noda A, Godbout E, Stevens M, Noda C. Levofloxacin for Antibacterial Prophylaxis in Pediatric Patients With Acute Myeloid Leukemia or Undergoing Hematopoietic Stem Cell Transplantation. J Pediatr Pharmacol Ther. 2020;25(7):629-635. doi: 10.5863/1551-6776-25.7.629.

  PMID: 33041718 RESULT

MeSH Terms

Conditions

Febrile Neutropenia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Idha Yulandari, M.D. Pediatric

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dr. Regina Amanda Putri, M.D

CONTACT

+6282322335677; reginamanda11@mail.ugm.ac.id

dr. Idha Yulandari, Sp.A, Fellow

CONTACT

+6281366659597; idhayulandari@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 07 October 2025 for 1,5 years
• Access Criteria: No data will be shared publicly. Data access will only be provided to qualified researchers upon justified request and with ethics approval.

Locations

ID (1)