TABLE 6

Proportion of subjects in the ME population with favorable clinical response at DCIV by baseline pathogena

PathogenResult for treatment groupREL vs placebo comparison, % difference (95% CI)b
250 mg REL + IMI (n = 81)125 mg REL + IMI (n = 86)Placebo + IMI (n = 83)250 mg REL + IMI125 mg REL + IMI
n/m%n/m%n/m%
Gram-positive aerobic cocci32/3210032/3397.033/3497.12.9 (−8.1 to 15.1)−0.1 (−12.9 to 12.4)
    Enterococcus faecalis7/71005/51005/51000.0 (−37.4 to 45.6)0.0 (−46.1 to 46.1)
    Streptococcus anginosus5/51006/61007/71000.0 (−45.6 to 37.4)0.0 (−41.0 to 37.3)
    Streptococcus constellatus2/21005/683.36/61000.0−16.7 (−57.9 to 28.5)
Gram-negative aerobic bacilli73/7597.373/7310068/7294.42.9 (−4.4 to 11.2)5.6 (0.4 to 13.5)
    Enterobacter cloacae7/71004/41004/41000.0 (−37.6 to 51.4)0.0 (−52.3 to 52.3)
    Escherichia coli53/5596.456/5610047/5192.24.2 (−5.7 to 15.4)7.8 (1.1 to 18.6)
    Klebsiella pneumoniae10/1010012/1210010/1283.316.7 (−14.4 to 45.5)16.7 (−10.6 to 45.4)
    Proteus mirabilis8/81004/41006/61000.0 (−34.1 to 40.8)0.0 (−51.6 to 41.6)
    Pseudomonas aeruginosa11/1110013/1310010/1283.316.7 (−12.4 to 45.5)16.7 (−9.0 to 45.4)
Gram-negative anaerobic bacilli22/2491.730/3010026/2796.3−4.6 (−23.0 to 11.4)3.7 (−8.1 to 18.5)
    Bacteroides fragilis11/111008/810012/121000.0 (−26.7 to 25.1)0.0 (−33.6 to 25.2)
    Bacteroides thetaiotaomicron6/61006/61006/785.714.3 (−29.9 to 52.8)14.3 (−29.9 to 52.8)
  • a The most common pathogens (those with at least 15 unique baseline isolates) are shown. CI, confidence interval; IMI, imipenem-cilastatin; n/m, number of subjects with pathogen and favorable clinical response/number of subjects with pathogen and clinical response assessment. Subjects with an indeterminate or missing response are excluded from the analysis.

  • b The 95% confidence intervals are based on the unconditional asymptotic Miettinen and Nurminen method without stratification.