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

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.

NCT Number	NCT07320534
Lead Sponsor	Gadjah Mada University Collaborators: Dr. Sardjito Hospital, Yogyakarta
Conditions	Neutropenic Fever, Acute Lymphoblastic Leukemia
Enrollment	124 participants
Start Date	2026-01-01
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-08