NCT07320534

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Gadjah Mada University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neutropenic Fever
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
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)
OTHER	Placebo	Receiving oral placebo at the same dosage as the treatment group.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-07-31
• Completion: 2026-08-31
• First posted: 2026-01-06
• Last updated: 2026-01-08

Locations

1 site across 1 country: Indonesia