p;
Klebsiella oxytoca
19/20 (95.0) 17/19 (89.5)
Klebsiella pneumoniae
42/47 (89.4) 46/53 (86.8)
Enterococcus faecalis
29/38 (76.3) 35/47 (74.5)
Methicillin-susceptible Staphylococcus aureus (MSSA)
26/28 (92.9) 22/24 (91.7)
Methicillin-resistant Staphylococcus aureus (MRSA) 16/18 (88.9) 1/3 (33.3)
Streptococcus anginosus grp.b 101/119 (84.9) 60/79 (75.9)
Bacteroides fragilis
68/88 (77.3) 59/73 (80.8)
Bacteroides thetaiotaomicron
36/41 (87.8) 31/36 (86.1)
Bacteroides uniformis
12/17 (70.6) 14/16 (87.5)
Bacteroides vulgatus
14/16 (87.5) 4/6 (66.7)
Clostridium perfringens
18/19 (94.7) 20/22 (90.9)
Peptostreptococcus micros
13/17 (76.5) 8/11 (72.7)
14.3 Community-Acquired Bacterial Pneumonia
TYGACIL was eva luated in adults for the treatment of community-acquired bacterial pneumonia (CABP) in two randomized, double-blind, active-controlled, multinational, multicenter studies (Studies 308 and 313). These studies compared TYGACIL (100 mg intravenous initial dose followed by 50 mg every 12 hours) with levofloxacin (500 mg intravenous every 12 or 24 hours). In one study (Study 308), after at least 3 days of intravenous therapy, a switch to oral levofloxacin (500 mg daily) was permitted for both treatment arms. Total therapy was 7 to 14 days. Patients with community-acquired bacterial pneumonia who required hospitalization and intravenous therapy were enrolled in the studies. The primary efficacy endpoint was the clinical response at the test of cure (TOC) visit in the co‑primary populations of the clinically eva luable (CE) and clinical modified intent-to-treat (c‑mITT) patients. See Table 10. Clinical cure rates at TOC by pathogen in the microbiologically eva luable patients are presented in Table 11.
Table 10. Clinical Cure Rates from Two Studies in Community-Acquired Bacterial Pneumonia after 7 to 14 Days of Total Therapy TYGACILa
n/N (%) Levofloxacinb
n/N (%) 95% CIc
a 100 mg initially, followed by 50 mg every 12 hours
b Levofloxacin (500 mg intravenous every 12 or 24 hours)
c 95% confidence interval for the treatment difference
d After at least 3 days of intravenous therapy, a switch to oral levofloxacin (500 mg daily) was permitted for both treatment arms in Study 308.
Study 308d
CE 125/138 (90.6) 136/156 (87.2) (-4.4, 11.2)
c-mITT 149/191 (78) 158/203 (77.8) (-8.5, 8.9)
Study 313
CE 128/144 (88.9) 116/136 (85.3) (-5.0, 12.2)
c-mITT 170/203 (83.7) 163/200 (81.5) (-5.6, 10.1)
Table 11. Clinical Cure Rates By Infecting Pathogen in Microbiologically eva luable Patients with Community-Acquired Bacterial Pneumoniaa Pathogen TYGACIL
n/N (%) Levofloxacin
n/N
(%)
a Two CABP studies
b Includes cases of concurrent bacteremia [cure rates of 20/22 (90.9%) ve |
