Clinical study on levofloxacin injection for surgical infection

We evaluated the efficacy and safety of levofloxacin (LVFX) injection 500 mg once-daily by intravenous infusion for 3 days to 14 days in patients with the secondary infections of injury, burns, or surgical wounds, acute cholecystitis, or acute cholangitis. The utility of sequential therapies, from LVFX injection to LVFX oral agent, for the treatment of surgical infection was evaluated. Additionally, the drug penetration into gallbladder bile and duct bile after administrating 500 mg of LVFX by injection was determined in patients with biliary tract infections. Clinical efficacy: The clinical efficacy rate at test of cure (primary endpoint) was 90.0% (9/10) in patients with the secondary infections of injury, burns or surgical wounds. All five patients with acute cholecystitis and all three patients with acute cholangitis were evaluated as cured. Microbiological efficacy: The microbiological efficacy rate at test of cure was 90.0% (9/10) in patients with the secondary infections of injury, burns or surgical wounds. Three (out of five) patients with acute cholecystitis and three patients with acute cholangitis were evaluated as demonstrating microbial eradication. Pharmacokinetics: The concentration of LVFX in gallbladder bile and duct bile after administrating LVFX injections was measured in two patients with acute cholecystitis (gallbladder bile) and four patients with acute cholangitis (duct bile). The LVFX concentration in gallbladder bile 3 h after starting infusion in the two patients was 13.9 μg/mL and 24.5 μg/mL, respectively. The gallbladder bile to plasma concentration ratios were 1.78 and 2.16, respectively. The mean value of the LVFX concentration in duct bile 3 h after starting infusion in the four patients was 12.0 jig/mL (range: 9.0 μg/mL-15.6 μg/mL). The mean value of duct bile to plasma concentration ratio was 1.82 (range: 1.37-2.31). Safety: The incidence rates of adverse events (AEs) and adverse drug reactions (ADRs) were 63.6% (14/ 22) and 13.6% (3/22), respectively. The severities of all ADRs were mild, and all patients who had any ADRs recovered. From these results, LVFX injection 500 mg once-daily was shown to be useful for the treatment of the secondary infections of injury, burns, or surgical wounds, acute cholecystitis, and acute cholangitis, and it was demonstrated that there were no significant problems with its safety.