title: Clinical and bacteriological efficacies of sitafloxacin against community-acquired pneumonia caused by Streptococcus pneumoniae: nested cohort within a multicenter clinical trial.
abstract: We evaluated the clinical and bacteriological efficacy of oral sitafloxacin (STFX) in clinically diagnosed community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae. Additionally, we cultured these patient samples to test the minimal inhibitory concentrations (MICs) of levofloxacin (LVFX), moxifloxacin (MFLX), STFX, and penicillin G (PCG), as well as identified mutations in the quinolone resistance determinant regions (QRDRs) in LVFX-resistant strains. This study is a nested cohort from a prospective, multicenter clinical trial consisting of 139 patients with community-acquired pneumonia (CAP), from which 72 were included in this study. After diagnosis of CAP caused by S. pneumoniae, STFX (50 mg twice daily, or 100 mg once daily) was orally administered for 7 days. Sixty-five patient sputum samples were then cultured for MIC analysis. In a LVFX-resistant strain that was identified, mutations in the QRDRs of the gyrA, gyrB, parC, and parE genes were examined. Of 72 patients eligible for this study, S. pneumoniae was successfully cultured from the sputum of 65 patients, and only 7 patients were diagnosed by urinary antigen only. Clinical improvement of CAP was obtained in 65 of the 69 clinically evaluable patients (65/69, 94.2 %). Eradication of S. pneumoniae was observed in 62 patients of the 65 bacteriologically evaluable patients (62/65, 95.4 %). Additionally, STFX showed the lowest MIC distribution compared with LVFX, MFLX, and PCG, and no major adverse reactions were observed. STFX treatment in patients with CAP caused by S. pneumoniae was found to be highly effective both clinically (94.2 %) and bacteriologically (95.4 %).
authors.affiliation: Department of Infectious, Respiratory, and Digestive Medicine, Control and Prevention of Infectious Diseases (First Department of Internal Medicine), Faculty of Medicine, University of the Ryukyus, 207 Uehara, Nishihara-cho, Okinawa, 903-0125, Japan. fujita@med.u-ryukyu.ac.jp
authors.forename: Jiro
authors.initials: J
authors.lastname: Fujita
authors.forename: Yoshihito
authors.initials: Y
authors.lastname: Niki
authors.forename: Jun-Ichi
authors.initials: J
authors.lastname: Kadota
authors.forename: Katsunori
authors.initials: K
authors.lastname: Yanagihara
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Kaku
authors.forename: Akira
authors.initials: A
authors.lastname: Watanabe
authors.forename: Nobuki
authors.initials: N
authors.lastname: Aoki
authors.forename: Seiji
authors.initials: S
authors.lastname: Hori
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Tanigawara
authors.forename: Haley L
authors.initials: HL
authors.lastname: Cash
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kohno
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D015331:Cohort Studies; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011018:Pneumonia, Pneumococcal / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D013296:Streptococcus pneumoniae / Q000187:drug effects
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; C076246:sitafloxacin