TABLE 5.

Overall clinical, radiological, and bacteriological efficacy results at test of cure or end of therapy

PopulationaSuccess rate, no. of successes/no. in group (% successes), amoxicillin-clavulanate 2,000/125 mg vs amoxicillin- clavulanate 875/125 mgTreatment difference, % (95% CI)
Clinical response at test of cure
    Clinical PP populationb223/247 (90.3) vs 198/226 (87.6)2.7 (−3.0, 8.3)
    ITT population274/322 (85.1) vs 243/311 (78.1)7.0 (0.9, 13.0)
Clinical response at end of therapy
    Clinical PP population250/266 (94.0) vs 223/242 (92.1)1.8 (−2.6, 6.3)
    ITT population291/322 (90.4) vs 264/311 (84.9)5.5 (0.4, 10.6)
Bacteriological response at test of cure
    Bacteriology PP population58/67 (86.6) vs 40/51 (78.4)8.1 (−5.8, 22.1)
    Bacteriology ITT population73/87 (83.9) vs 49/73 (67.1)16.8 (3.5, 30.0)
Bacteriological response at end of therapy
    Bacteriology PP population67/74 (90.5) vs 47/57 (82.5)8.1 (−3.8, 20.0)
    Bacteriology ITT population75/87 (86.2) vs 57/73 (78.1)8.1 (−3.8, 20.1)
Radiological response at test of cure
    Clinical PP population230/247 (93.1) vs 204/226 (90.3)2.9 (−2.1, 7.8)
    ITT population281/322 (87.3) vs 254/311 (81.7)5.6 (−0.0, 11.2)
  • a See Table 3, footnote a.

  • b Primary efficacy endpoint.