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Levofloxacin Prophylaxis During Induction Therapy for Pediatric Acute Lymphoblastic Leukemia
Joshua Wolf1,2,3, Li Tang4, Patricia M Flynn1,2
1Departments of Infectious Diseases.
Insights
Antibacterial prophylaxis, particularly with levofloxacin, significantly reduced infections in children with acute lymphoblastic leukemia (ALL). This approach also decreased C. difficile infections and broad-spectrum antibiotic use during chemotherapy.
Area of Science:
- Pediatric Oncology
- Infectious Diseases
- Pharmacology
Background:
- Infection is a major cause of morbidity and mortality in pediatric acute lymphoblastic leukemia (ALL) patients.
- Antibacterial prophylaxis is standard in adults but debated in pediatrics due to limited evidence and concerns about resistance.
- Concerns include promoting antibiotic resistance and Clostridium difficile infection.
Purpose of the Study:
- To evaluate the efficacy and safety of antibacterial prophylaxis during induction therapy for pediatric ALL.
- To compare infection-related outcomes between no prophylaxis, levofloxacin, and other prophylaxis regimens.
- To assess the impact of prophylaxis on antibiotic resistance and C. difficile infections.
Main Methods:
- Single-center, observational cohort study of newly diagnosed ALL patients.
- Prospective collection of infection-related outcomes during induction therapy.
- Propensity score-weighted logistic regression used to adjust for confounders.
Main Results:
- Prophylaxis was associated with a longer duration of neutropenia.
- Antibacterial prophylaxis reduced febrile neutropenia, likely bacterial infections, and bloodstream infections by over 70%.
- Levofloxacin prophylaxis reduced C. difficile infections by over 95% and minimized exposure to other antibiotics without increasing resistant organism infections.
Conclusions:
- This study supports antibacterial prophylaxis with levofloxacin in pediatric ALL patients undergoing induction chemotherapy.
- Levofloxacin prophylaxis effectively prevented febrile neutropenia and systemic infections.
- Levofloxacin prophylaxis reduced C. difficile infections and the need for other antibiotics, warranting further monitoring for antibiotic resistance.
Background:
Infection is the most important cause of treatment-related morbidity and mortality in pediatric patients treated for acute lymphoblastic leukemia (ALL). Although routine in adults with leukemia, antibacterial prophylaxis is controversial in pediatrics because of insufficient evidence for its efficacy or antibiotic choice and concerns about promoting antibiotic resistance and Clostridium difficile infection.
Methods:
This was a single-center, observational cohort study of patients with newly diagnosed ALL, comparing prospectively collected infection-related outcomes in patients who received no prophylaxis, levofloxacin prophylaxis, or other prophylaxis during induction therapy on the total XVI study. A propensity score-weighted logistic regression model was used to adjust for confounders.
Results:
Of 344 included patients, 173 received no prophylaxis, 69 received levofloxacin prophylaxis, and 102 received other prophylaxis regimens. Patients receiving prophylaxis had longer duration of neutropenia. Prophylaxis reduced the odds of febrile neutropenia, likely bacterial infection, and bloodstream infection by ≥70%. Levofloxacin prophylaxis alone reduced these infections, but it also reduced cephalosporin, aminoglycoside, and vancomycin exposure and reduced the odds of C. difficile infection by >95%. No increase in breakthrough infections with antibiotic-resistant organisms was seen, but this cannot be excluded.
Conclusions:
This is the largest study to date of antibacterial prophylaxis during induction therapy for pediatric ALL and the first to include a broad-spectrum fluoroquinolone. Prophylaxis prevented febrile neutropenia and systemic infection. Levofloxacin prophylaxis also minimized the use of treatment antibiotics and drastically reduced C. difficile infection. Although long-term antibiotic-resistance monitoring is needed, these data support using targeted prophylaxis with levofloxacin in children undergoing induction chemotherapy for ALL.
Clinical Trials Registration:
NCT00549848.
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