Vancomycin/Aztreonam
n/N (%)
a Two cSSSI pivotal studies and two Resistant Pathogen studies
b Includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus
Escherichia coli
29/36 (80.6) 26/30 (86.7)
Enterobacter cloacae
10/12 (83.3) 15/15 (100)
Enterococcus faecalis (vancomycin-susceptible only) 15/21 (71.4) 19/24 (79.2)
Klebsiella pneumoniae
12/14 (85.7) 15/16 (93.8)
Methicillin-susceptible Staphylococcus aureus (MSSA)
124/137 (90.5) 113/120 (94.2)
Methicillin-resistant Staphylococcus aureus (MRSA) 79/95 (83.2) 46/57 (80.7)
Streptococcus agalactiae
8/8 (100) 11/14 (78.6)
Streptococcus anginosus grp.b 17/21 (81.0) 9/10 (90.0)
Streptococcus pyogenes
31/32 (96.9) 24/27 (88.9)
Bacteroides fragilis
7/9 (77.8) 4/5 (80.0)
14.2 Complicated Intra-abdominal Infections
TYGACIL was eva luated in adults for the treatment of complicated intra-abdominal infections (cIAI) in two randomized, double-blind, active-controlled, multinational, multicenter studies (Studies 301 and 306). These studies compared TYGACIL (100 mg intravenous initial dose followed by 50 mg every 12 hours) with imipenem/cilastatin (500 mg intravenous every 6 hours) for 5 to 14 days. Patients with complicated diagnoses including appendicitis, cholecystitis, diverticulitis, gastric/duodenal perforation, intra-abdominal abscess, perforation of intestine, and peritonitis were enrolled in the studies. The primary efficacy endpoint was the clinical response at the TOC visit for the co-primary populations of the microbiologically eva luable (ME) and the microbiologic modified intent-to-treat (m-mITT) patients. See Table 8. Clinical cure rates at TOC by pathogen in the microbiologically eva luable patients are presented in Table 9.
Table 8. Clinical Cure Rates from Two Studies in Complicated Intra-abdominal Infections after 5 to 14 Days of Therapy TYGACILa
n/N (%) Imipenem/Cilastatinb
n/N (%)
a 100 mg initially, followed by 50 mg every 12 hours
b Imipenem/Cilastatin (500 mg every 6 hours)
Study 301
ME 199/247 (80.6) 210/255 (82.4)
m-mITT 227/309 (73.5) 244/312 (78.2)
Study 306
ME 242/265 (91.3) 232/258 (89.9)
m-mITT 279/322 (86.6) 270/319 (84.6)
Table 9. Clinical Cure Rates By Infecting Pathogen in Microbiologically eva luable Patients with Complicated Intra-abdominal Infectionsa Pathogen TYGACIL
n/N (%) Imipenem/Cilastatin
n/N (%)
a Two cIAI pivotal studies and two Resistant Pathogen studies
b Includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus
Citrobacter freundii
12/16 (75.0) 3/4 (75.0)
Enterobacter cloacae
15/17 (88.2) 16/17 (94.1)
Escherichia coli
284/336 (84.5) 297/342 (86.8)&nbs |
