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
Abstract
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.
Primary outcome: Median time to first febrile neutropenia; Clinical Outcome.
Enrollment: 49 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 49 participants or records.
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