The Efficacy and Safety of Prophylactic Levofloxacin in reducing the incidence of Febrile Neutropenia and Bacterial Infection during Induction and Consolidation Chemotherapy in Pediatric patients aged 1 to 18 years with Acute Lymphoblastic Leukemia (ALL) and Lymphoma: A randomized controlled trial

Title: Efficacy and Safety of Prophylactic Levofloxacin in Reducing Febrile Neutropenia during Chemotherapy in Pediatric ALL and Lymphoma: A Randomized Controlled Trial

Background:

• Acute Lymphoblastic Leukemia (ALL) is the most common childhood cancer.
• In India, infection-related complications during chemotherapy-induced neutropenia remain a leading cause of morbidity, mortality, and treatment delays.
• Febrile Neutropenia (FN) incidence in Indian children during induction is 60–80%, often due to gram-negative infections.
• Levofloxacin prophylaxis has shown benefit internationally but its role in Indian settings with high antimicrobial resistance and resource constraints is unclear.

Aim: To evaluate whether prophylactic levofloxacin reduces FN and bacterial infections during induction and consolidation chemotherapy in children with ALL/Lymphoma.

Methodology:

• Design: Open-label, randomized controlled trial.
• Participants: 102 children (1–18 years) with newly diagnosed ALL/Lymphoma (51 per arm).
• Intervention: Levofloxacin 10 mg/kg/day (max 500 mg), oral, from start of induction until 7 days after consolidation.
• Control: Standard of care without levofloxacin prophylaxis.
• Primary Outcome: Incidence of FN.
• Secondary Outcomes: Infection rates, antibiotic use, hospitalization/ICU stay, chemotherapy delays, mortality, and resistance patterns.
• Analysis: SPSS v23, significance at p < 0.05.

Ethics & Safety:

• Informed consent/assent in Hindi and English.
• Short-term levofloxacin considered safe; adverse events graded by CTCAE v5.0.

Expected Impact:

• Generate India-specific evidence for levofloxacin prophylaxis.
• Potential to reduce FN burden, improve chemotherapy compliance, cut costs, and enhance survival in pediatric ALL in resource-limited settings.