Vol. 6, Issue 2, Part C (2024)

Background: Levofloxacin prophylaxis prevents infections in children undergoing acute lymphoblastic leukemia (ALL) treatment, particularly during the induction therapy phase when patients are highly immunocompromised. The antibiotic levofloxacin has been considered as a preventive measure to reduce these risks in a controlled healthcare setting. This study aimed to evaluate the role of prophylactic Levofloxacin among these pediatric acute lymphoblastic leukemia (ALL) patients and compare the outcome.
Methods: This quasi-randomized clinical trial was conducted over 12 months at the Department of Pediatric Hematology & Oncology, Bangabandhu Sheikh Mujib Medical University (BSMMU). In this study, participants were randomly assigned into two equal groups of 40 patients each. Group A received levofloxacin as prophylaxis, whereas Group B did not. The outcome measures included assessments of various types of neutropenia, febrile neutropenia, clinically documented infections, microbiologically documented infections, and drug-related events. Data analysis was performed using SPSS 23.0.
Results: Group A showed a marked reduction in fever during the first, third, fourth, and fifth treatment weeks (p<0.05) and less oral mucositis in the fifth week (p=0.023). It had lower hypokalemia incidence, notably in the third week (p=0.043), and reduced febrile neutropenia (45.0% vs. 67.5%; p=0.042) compared to Group B. Group B had Prolonged Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT), with significant APTT differences in the third to fifth weeks (p=0.025, p<0.001, p<0.001). Furthermore, it had more clinically documented infection (CDI) and microbiologically documented infection (MDI) requiring parenteral antibiotics (p<0.05).
Conclusion: The results suggest that administering Levofloxacin prophylaxis to newly diagnosed pediatric acute lymphoblastic leukemia (ALL) patients during the induction phase effectively reduces febrile episodes, febrile neutropenia, and infections. Therefore, it could be considered for prophylactic use alongside the chemotherapy protocol for children with ALL in the induction period.