Alexander S, et al. - In children receiving intensive chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (HSCT), researchers determined the effectiveness and risks of levofloxacin prophylaxis. They found that levofloxacin prophylaxis vs no prophylaxis lead to a significant reduction in bacteremia among children with acute leukemia receiving intensive chemotherapy. Among children undergoing HSCT, no significant reduction in bacteremia with levofloxacin prophylaxis was noted.

Methods

• This multicenter, open-label, randomized trial enlisted patients (6 months-21 years) receiving intensive chemotherapy (September 2011-April 2016) in 2 groups—acute leukemia, consisting of acute myeloid leukemia or relapsed acute lymphoblastic leukemia, and HSCT recipients—at 76 centers in the US and Canada, with follow-up completed September 2017.
• For this investigation, patients with acute leukemia were randomized to receive levofloxacin prophylaxis for 2 consecutive cycles of chemotherapy (n = 100) or no prophylaxis (n = 100).
• Patients undergoing HSCT were randomized to receive levofloxacin prophylaxis during 1 HSCT procedure (n = 210) or no prophylaxis (n = 214).
• The occurrence of bacteremia during 2 chemotherapy cycles (acute leukemia) or 1 transplant procedure (HSCT) was the primary outcome.
• Fever and neutropenia, severe infection, invasive fungal disease, Clostridium difficile–associated diarrhea, and musculoskeletal toxic effects were the secondary outcomes.

Results

• An aggregate of 624 subjects, 200 with acute leukemia (median [interquartile range {IQR}] age, 11 years [6-15 years]; 46% female) and 424 undergoing HSCT (median [IQR] age, 7 years [3-14]; 38% female), were selected.
• The likelihood of bacteremia was significantly lower in the levofloxacin prophylaxis group vs the control group (21.9% vs 43.4%; risk difference, 21.6%; 95% CI, 8.8%-34.4%, P=.001) among 195 patients with acute leukemia.
• The risk of bacteremia was not significantly lower in the levofloxacin prophylaxis group (11.0% vs 17.3%; risk difference, 6.3%; 95% CI, 0.3%-13.0%; P=.06) among 418 patients undergoing HSCT.
• In the levofloxacin group (71.2% vs 82.1%; risk difference, 10.8%; 95% CI, 4.2%-17.5%; P=.002), fever and neutropenia were less common.
• No significant differences were found in severe infection (3.6% vs 5.9%; risk difference, 2.3%; 95% CI, -1.1% to 5.6%; P=.20), invasive fungal disease (2.9% vs 2.0%; risk difference, -1.0%; 95% CI, -3.4% to 1.5%, P=.41), C difficile–associated diarrhea (2.3% vs 5.2%; risk difference, 2.9%; 95% CI, -0.1% to 5.9%; P=.07), or musculoskeletal toxic effects at 2 months (11.4% vs 16.3%; risk difference, 4.8%; 95% CI, -1.6% to 11.2%; P=.15) or at 12 months (10.1% vs 14.4%; risk difference, 4.3%; 95% CI, -3.4% to 12.0%; P=.28) between the levofloxacin and control groups.