Antibiotic prophylaxis reduces the risk of bacteraemia for children with acute leukaemia undergoing chemotherapy, results from a multicentre phase III trial suggest.
However, antibiotic prophylaxis does not significantly reduce the likelihood of bacteraemia in children undergoing hematopoietic stem cell transplantation (HSCT)
Bacteraemia is a leading cause of morbidity and mortality in children with leukaemia who have neutropenia secondary to intensive chemotherapy, and also for those undergoing HSCT, according to Canadian researchers.
And while there is evidence to support the use of prophylactic antibiotics in adult patients, data in children is limited.
They therefore conducted a RCT involving 195 children with acute leukaemia treated with intensive chemotherapy. The primary endpoint of bacteraemia occurred in 21.9% of the cohort randomised to levofloxacin compared with 43.4% of children who received no prophylaxis, according to lead investigator Dr Sarah Alexander from the Hospital for Sick Children in Toronto, and colleagues writing in JAMA.
In the 418 patients receiving haematopoietic stem cell transplantation (HSCT) levofloxacin showed a numerical advantage in bacteremia reduction (11.0% versus 17.3% with no prophylaxis), but this this did not reach statistical significance.
“It is possible that the effect was similar in the 2 groups but there was a reduced power to detect a significant difference related to fewer events among patients undergoing HSCT,” the study authors noted.
The secondary endpoints of fever and neutropenia among all patients in the study, occurred in 71.2% of those on levofloxacin compared with 82.1% of those who received no prophylaxis and fewer patients on levofloxacin needed therapeutic antibiotics (68.6% versus 85.7%).
The researcher noted that they still observed many viridans group streptococcal and gram-negative bacteraemia in the prophylaxis group.
“This finding suggests that levofloxacin prophylaxis will not eliminate the risk of these important infections,” they cautioned.
The adoption of antibacterial prophylaxis is also tempered by potential negative consequences including Clostridium difficile–associated diarrhoea, bacterial resistance, and musculoskeletal toxicities, they noted.
However in the trial positive C difficile test results were less common among levofloxacin prophylaxis recipients and there was no evidence of increased acquisition of resistance in S. mitis, E. coli, K. pneumonia, and P. aeruginosa isolates. The trial did not identify a difference in the reported rates of musculoskeletal conditions between levofloxacin and no treatment, although the study was not powered to detect a significant difference.