Rahman, M.M., & Khan, M.A. (2009). Levofloxacin prophylaxis to prevent bacterial infection in chemotherapy-induced neutropenia in acute leukemia. Bangladesh Medical Research Council Bulletin, 35(3), 91–94.

The purpose of the study was to evaluate if prophylaxis with oral levofloxacin will reduce or delay the febrile neutropenic episodes in chemotherapy-induced neutropenia.

Patients enrolled were assigned randomly to receive 500 mg of levofloxacin orally once daily, or an identical-appearing placebo, starting on day 1 of chemotherapy. Prophylaxis was continued until neutropenia had resolved or fever was documented. Patients were examined daily for clinical signs of infection.

The primary end point of the study was the occurrence of fever, requiring empirical antibacterial therapy during neutropenia. Secondary end points were the type and number of documented infections, the use of parenteral antimicrobial agents during neutropenia, survival at the resolution of neutropenia, compliance, and tolerability.
 

• 80 adult patients made up the sample
• Female, 35%
• Male, 65%
• All had a diangosis of acute leukemia

Active treatment
 

Prospective, randomized, placebo-controlled, single-blinded study.

• Time to first fever requiring empiric antibiotic coverage
• In non-neutropenic patients, axillary temperature exceeded 101°F and, in neutropenic patients (absolute neutrophil count of less than 500/mm³), a single oral temperature of 101ºF or higher, or a temperature of 100°F or higher for more than one hour, was taken as a sign of infection or septicemia.
• Type and number of documented infections
• Survival at the resolution of neutropenia
• Compliance
   

Levofloxacin prophylaxis reduced the incidence of fever (17/25 patients (68%) compared to18/23 patients (78%) in placebo group; relative risk = 0.87; absolute difference in risk = 10%, p < 0.001) and reduced the incidence of microbiological proven infection (4/25 [16%] in the levofloxacin group compared to 7/23 [30.4%] in the placebo group; relative risk = 0.52; absolute difference in risk = 14.4%; p < 0.001). However, patients in the levofloxacin group were more likely to have a fever that lasted more than seven days (23%) compared with the control group (12.5%, p not stated).

This prospective study does not make a strong case for the use of levofloxacin to prevent neutropenic fever in patients with acute leukemia..

• The sample size was small (less than 100).
• The statistical analysis was not described. It appears that the study is not adequately powered to detect differences between the treatment groups.
• Levofloxacin prophylaxis was started on day 1 of chemotherapy in this study, rather than after the chemotherapy in anticipation of the chemotherapy nadir, which is the more common practice.
• The risk of antibiotic resistance is a concern which is not evaluated in this study.
• This study was conducted in Bangladesh and the authors stated the concern that the hospital environment was not hygienic, so the data may not be applicable to the hospital setting in other countries.
• The statistical analyses do not appear adequate to use the data to make any definitive recommendations about levofloxacin prophylaxis.
   

This study suggests that levofloxacin may reduce fever and infection in patients with acute leukemia. There is a concern regarding antibiotic resistance with the use of prophylactic antibiotics.