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Efficacy of tigecycline (TGC) compared with levofloxacin (LEV) for treating Streptococcus pneumoniae bacteraemia in patients (pts) hospitalised with community-acquired pneumonia (CAP)

Abstract number: 1733_346

Dartois N., Dukart G., Cooper C.A., Castaing N., Gandjini on behalf of the 308 H., Groups 313 Study

Objective: Tigecycline (TGC), a first-in-class glycylcycline approved for treating complicated skin/skin structure and intra-abdominal infections, has an expanded spectrum of activity against Gram-positive, Gram-negative and atypical bacteria including some resistant strains. CAP pts with Streptococcus pneumoniae bacteraemia frequently have more severe disease and increased mortality than pts without bacteraemia. We evaluated the efficacy and safety of TGC vs. levofloxacin (LEV) in a subset of hospitalised CAP pts with pneumococcal bacteraemia.

Method: Two Phase 3, multicentre, double blind studies were conducted in hospitalised CAP pts. Pts were randomised to receive IV TGC (100 mg then 50 mg ql2h) or IV LEV (500 mg q24h or q12h). In 1 study, pts could be switched to oral LEV after ≥3 days of IV dosing. Clinical response was evaluated at test-of-cure (TOC). Results are presented for the microbiologically evaluable (ME) and microbiologic modified intent-to-treat (m-mITT) populations.

Results: 846 pts received at least 1 dose of study drug in these 2 trials. Of the 345 ME and 457 m-mITT pts, 40 (11.6%) and 50 (10.9%) pts, respectively, had S. pneumoniae (sp.) bacteraemia. At TOC (ME population), TGC cured 20/22 (90.9%)and LEV cured 13/18 (72.2%) – absolute difference TGC–LEV, 18.7% (95% CI -8.8, 45.6). The cure rate for TGC in sp. bacteraemic pts was similar to that of TGC in ME pts without sp. bacteraemia (127/138, 92.0%). The cure rate for LEV in bacteraemic pts (ME) was numerically lower than that for LEV pts without bacteraemia (146/159, 91.8%). In the m-mITT population, TGC cured 22/27 (81.5%) and LEV cured 15/23 pts (65.2%) – absolute difference TGC–LEV 16.3% (95% CI -10.5, 41.4). Again, the cure rate for TGC in sp. bacteraemic pts was similar to that achieved by TGC in pts without sp. bacteraemia (162/189, 85.7%), whereas the cure rate for LEV was lower in bacteraemic vs. non-bacteraemic pts (177/203, 87.2%). The minimum inhibitory concentration (MIC) of TGC for S. pneumoniae blood isolates ranged from 0.03–0.12 mg/mL, whereas the MIC of LEV for these isolates ranged from 0.5–1.0 mg/mL.

Conclusions: In these 2 studies, TGC appeared safe and achieved cure rates similar to LEV in hospitalised pts with CAP. Further, in a subset of pts with S. pneumoniae bacteraemia, TGC achieved cure rates similar to those in TGC-treated CAP pts without bacteraemia. Finally, TGC achieved a numerically higher cure rate than LEV, although the difference was not statistically significant.

Session Details

Date: 31/03/2007
Time: 00:00-00:00
Session name: European Society of Clinical Microbiology and Infectious Diseases
Subject:
Location: ICC, Munich, Germany
Presentation type:
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