Garenoxacin is a type of fluoroquinolone antibacterial agents. Previous studies have suggested that garenoxacin 400mg once daily dose is appropriate for patients with normal to moderate renal disfunction against common bacteria of respiratory infections. However, limited information has been obtained in terms of treatment for severe renal failure patients, such as hemodialysis patients, with this drug. Twenty severe renal failure patients with respiratory infection received single garenoxacin dose (200mg and 400mg). By measuring blood concentration of garenoxacin, pharmacodynamics parameters, such as the peak plasma concentration (C_max) and the area under the concentration curve (AUC), were calculated with NONMEM^®. After single dose of garenoxacin, C_max at the 200 and 400mg doses were within the range of 2.9±0.6 and 6.0 ±1.0 μg/mL, respectively. The corresponding values for AUC at the 200 and 400mg doses were within the ranges of 62.3±11.9 and 128.0±12.5 μg・hr/mL, respectively. The mean half-life (T_1/2) for garenoxacin appeared to be independent of dose (13.9±2.2 hr and 13.7±1.9 hr at the 200 and 400mg dose). There were no serious adverse events suspected to be related with garenoxacin. Consequently, for severe renal failure patients, the 400mg once daily garenoxacin dose was expected to be effective against common bacteria of respiratory infections.

This is an integrated summary of the results obtained from a 3-decade multicenter study on bacteria isolated from surgical infections in Japan between July 1982 and March 2012.

During the 3-decade study, 11,196 strains were isolated from 4,787 patients consisting of 2,132 patients with primary infection and 2,655 patients with surgical site infection. Almost half of the primary infection was peritonitis, which accounted 42.3%-55.5%. In contrast, most of the surgical site infection was wound infections, which accounted for 49.3%-66.1%. The most commonly isolated bacteria throughout three decades were Escherichia coli (1,164 strains), Enterococcus faecalis (842), Staphylococcus aureus (833), Pseudomonas aeruginosa (706), Bacteroides fragilis (705), Klebsiella pneumoniae (498), Enterobacter clocae (391) and coagulase-negative staphylococci (CNS) (325).

Overall, S. aureus and CNS had sensitivity for vancomycin, whose MIC₉₀s were 0.78 to 3.13μg/mL; E. faecalis had sensitivity for vancomycin and imipenem, whose MIC₉₀s were 0.78～4μg/mL; E coli, E. cloacae, K. pneumoniae, and B. fragilis had preferable sensitivity for imipenem. No antibacterial agents had a long-term good activity (e.g. MIC₉₀<2μg/mL) for P. aeruginosa and Bilophila wadsworthia. Among antibacterial agents tested, ciprofloxacin had most bactericidal activity for P. aeruginosa; its MIC₉₀ varied from 0.5 to 8μg/mL. The MIC₉₀s of all antibacterial agents tested except levofloxacin and minocycline were at least 128μg/mL for B. wadsworthia.

S. aureus accounted for approximately 20% to 60% of bacteria isolated after clean operation. Overall, at least 55% of the bacteria isolated after clean operation consisted of S. aureus, CNS, E. faecalis, E. coli, E. cloacae, K. pneumoniae, P. aeruginosa, B. fragilis, and B. wadsworthia throughout three decades. However, the percentage of the other Gram-positive and negative bacteria increased with the worse of sterile condition in surgical operation.

E. faecalis tended to be most commonly isolated from patients having host-compromised factors including carcinoma, diabetes, anticancer agents, streroids, immunosuppressants, and radiation, while E. coli was commonly isolated from patients having no such factors.

Two-drug-resistant P. aeruginosa was first isolated in 1987, thereafter was frequently isolated, and reached 69 straains for 30 years. Three-drug-resistant P. aeruginosa was isolated in 1990, 1996, and 1998 to reach 5 strains, but not isolated in remaining 13 years.

Methicilin-resistant S. aureus was highly frequently isolated between 1998 and 1991. Subsequently, the isolation frequency declined, sometimes increased in 1998, 2005, and 2006, and thereafter mamintained lower levels by 2011.

To demonstrate clinical value of clavulanic acid/amoxicillin (CVA/AMPC) 1:14 combination dry syrup for acute bacterial rhinosinusitis (ABRS), the efficacy and safety were evaluated in a multicenter, open-label, uncontrolled study in 27 children with ABRS. The proportion of subjects who were ‘cured’ at the test of cure as the primary endpoint was 88.5%. In subjects with a major pathogenic bacteria at baseline (i.e., Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) bacterial eradication was achieved in ≥80% of the subjects with the excepti on of β-lactamase non-producing ampicillin resistant H. influenzae: BLNAR and β-lactamase producing ampicillin resistant H. influenzae: BLPAR (β-lactamase producing amoxicillin/clavulanic acid resistant H. influenzae: BLPACR). The MIC of CVA/AMPC (1: 14) was not higher than 4 μg/mL for all pathogens except one strain each of BLNAR and BLPAR (BLPACR). Drug-related adverse events were reported in 19% of patients (5/27 patients). All of the reported drug-related adverse events were classified as gastrointestinal disorders that have been commonly reported with antibacterial drugs.

These results indicate that CVA/AMPC (1:14) was clinically useful for the treatment of ABRS and is also suggested that was effective especially for the treatment of ABRS in children cause by beta-lactamase-producing bacteria including M. catarrahalis.