cIAI Data

Proven as effective as meropenem in 2 large Phase III clinical trials

  • The cIAI trials (Study 1 and Study 2) were identical multicenter, prospective, randomized, double-blind studies comparing DORIBAX® to meropenem1
    • Treatment duration and dosing were the same in both trials
    • DORIBAX®: 500 mg q8h (5-14 days) IV over 1 h; meropenem: 1 g q8h (5-14 days) IV bolus
  • Primary endpoint (both trials): noninferiority of the clinical cure rate at the test-of-cure (TOC) visit in microbiologically evaluable (ME) patients1
    • Study 1: DORIBAX® 82.8% (130/157) vs meropenem 85.9% (128/149)
    • Study 2: DORIBAX® 81.0% (128/158) vs meropenem 82.1% (119/145)

Overall per patient microbiological cure rates in ME population2

Adapted from Solomkin et al. 2007.2



Excellent pseudomonal eradication in 2 cIAI trials vs meropenem


Eradication rates against P aeruginosa in cIAI*1

Study 1—95% CI:-17.7, 38.7
Study 2—95% CI:-30.3, 44.2


  • * Microbiologically evaluable patients at TOC (subset analysis of patients with documented P aeruginosa infections).

cIAI microbiological cure rates by gram-negative pathogen (ME population)

 
Pathogen DORIBAX® Meropenem
Gram negative, aerobic N† n‡ % N† n‡ %
Enterobacteriaceae 315 271 86.0 274 234 85.4
E coli 216 189 87.5 199 168 84.4
K pneumoniae 32 25 78.1 20 19 95.0
Nonfermenters 51 44 86.3 39 28 71.8
P aeruginosa 40 34 85.0 32 24 75.0
Gram negative, anaerobic N† n‡ % N† n‡ %
B fragilis group 173 152 87.9 181 152 84.0
 

†N = number of unique baseline isolates.
‡n = number of pathogens assessed as cured.