TABLE 2

Time course of clinical and microbiological responses (mITT population)a

EndpointNo. of patients (% of patients [95% CI])
FINA05FINA10CIPRO10
Total64 (100.0)68 (100.0)61 (100.0)
Visit 2 (day 3)
    Combined endpoint39 (60.9 [47.9–72.9])40 (58.8 [46.2–70.6])33 (54.1 [40.8–66.9])
    Clinical success40 (62.5 [49.5–74.3])42 (61.8 [49.2–73.3])35 (57.4 [44.1–70.0])
    Microbiological eradication57 (89.1 [78.8–95.5])60 (88.2 [78.1–94.8])48 (78.7 [66.3–88.1])
End of therapy (day 10)
    Combined endpoint49 (76.6 [64.3–86.2])49 (72.1 [59.9–82.3])44 (72.1 [59.2–82.9])
    Clinical success56 (87.5 [76.8–94.4])55 (80.9 [69.5–89.4])49 (80.3 [68.2–89.4])
    Microbiological eradication49 (76.6 [64.3–86.2])53 (77.9 [66.2–87.1])45 (73.8 [60.9–84.2])
Test of cure (day 17) (primary endpoint)
    Combined endpoint45 (70.3 [57.6–81.1])46 (67.6 [55.2–78.5])35 (57.4 [44.1–70.0])
    Clinical success51 (79.7 [67.8–88.7])57 (83.8 [72.9–91.6])44 (72.1 [59.2–82.9])
    Microbiological eradication46 (71.9 [59.2–82.4])48 (70.6 [58.3–81.0])36 (59.0 [45.7–71.4])
End of study (day 24)
    Combined endpoint47 (73.4 [60.9–83.7])42 (61.8 [49.2–73.3])34 (55.7 [42.4–68.5])
    Clinical success52 (81.3 [69.5–89.9])53 (77.9 [66.2–87.1])43 (70.5 [57.4–81.5])
    Microbiological eradication48 (75.0 [62.6–85.0])44 (64.7 [52.2–75.9])36 (59.0 [45.7–71.4])
  • a Numbers of patients, percentages of patients, and 95% confidence intervals for the mITT population are given as a combined endpoint (both clinical and microbiological success) and with clinical success and microbiological eradication separately. The presented data are grouped by visit for patients receiving 800 mg finafloxacin once daily for 5 days (FINA05) or 10 days (FINA10) or 400/500 mg ciprofloxacin for 10 days (CIPRO10).