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

Gadjah Mada University

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Lymphoblastic Leukemia; Neutropenic Fever

Treatments: Drug: Levofloxacin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07320534

KE/FK/1504/EC/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups, including a placebo group

Group A: Levofloxacin

Experimental group

Description:

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)

Treatment:

Drug: Levofloxacin

Group B: Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo