rsus 13/18 (72.2%) for TYGACIL and levofloxacin respectively]
Haemophilus influenzae
14/17 (82.4) 13/16 (81.3)
Legionella pneumophila
10/10 (100.0) 6/6 (100.0)
Streptococcus pneumoniae (penicillin-susceptible
only)b 44/46 (95.7) 39/44 (88.6)
To further eva luate the treatment effect of tigecycline, a post-hoc analysis was conducted in CABP patients with a higher risk of mortality, for whom the treatment effect of antibiotics is supported by historical evidence. The higher-risk group included CABP patients from the two studies with any of the following factors:
Age ≥50 years
PSI score ≥3
Streptococcus pneumoniae bacteremia
The results of this analysis are shown in Table 12. Age ≥50 was the most common risk factor in the higher-risk group.
Table 12. Post-hoc Analysis of Clinical Cure Rates in Patients with Community-Acquired Bacterial Pneumonia Based on Risk of Mortalitya TYGACIL
n/N (%) Levofloxacin
n/N
(%) 95% CIb
a Patients at higher risk of death include patients with any one of the following: ≥50 year of age; PSI score ≥3; or bacteremia due to Streptococcus pneumoniae
b 95% confidence interval for the treatment difference
c 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 308c
CE
Higher risk
Yes 93/103 (90.3) 84/102 (82.4) (-2.3, 18.2)
No 32/35 (91.4) 52/54 (96.3) (-20.8, 7.1)
c-mITT
Higher risk
Yes 111/142 (78.2) 100/134 (74.6) (-6.9, 14)
No 38/49 (77.6) 58/69 (84.1) (-22.8, 8.7)
Study 313
CE
Higher risk
Yes 95/107 (88.8) 68/85 (80) (-2.2, 20.3)
No 33/37 (89.2) 48/51 (94.1) (-21.1, 8.6)
c-mITT
Higher risk
Yes 112/134 (83.6) 93/120 (77.5) (-4.2, 16.4)
No 58/69 (84.1) 70/80 (87.5) (-16.2, 8.8)
15 REFERENCES
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – 8th ed. Approved Standard, CLSI document M07-A8, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
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