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Efficacy of tigecycline versus levofloxacin in patients hospitalised with community-acquired pneumonia: analysis of risk factors

Abstract number: 1733_347

Dartois N., Dukart G., Cooper C., Castaing N., Gandjini I., Sarkozy on behalf of the 308 D., Groups 313 Study

Objective: The initial severity of community-acquired pneumonia (CAP) and eventual clinical outcome may be influenced by a number of risk factors. Tigecycline (TGC), a first-in-class glycylcycline approved for treating complicated skin/skin structure and intra-abdominal infections, exhibits expanded activity against Gram-positive, Gram-negative and atypical bacteria and some resistant strains. The efficacy of TGC vs levofloxacin (LEV) was studied in hospitalised pts with CAP. In addition to overall response, exploratory analyses were performed evaluating response to treatment for a variety of risk factors.

Method: Two Phase 3, multicentre, double blind studies were conducted in hospitalised pts with CAP who were randomised to receive IV TGC (100 mg initially 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. At randomisation, pts were stratified by: geographic location in 1 study and by Fine Pneumonia Severity Index in both studies. Clinical response was evaluated at test-of-cure. Risk factors, such as age, Fine Pneumonia Severity Index and estimated CURB-65 scores, and co-morbidities including diabetes (DM), chronic obstructive pulmonary disease, congestive heart failure (CHF) and cerebrovascular disease (CVD) were evaluated. Results will be presented for the clinically evaluable (CE) population.

Results: 846 pts received at least 1 dose of study drug in these 2 trials and the CE population consisted of 574 pts (TGC = 282, LEV = 292). Overall, the cure rates (CE) for TGC (253/282 pts, 89.7%) were similar to LEV (252/292, 86.3%). Although the number of pts was small for some subgroups, a statistically significant subgroup by treatment interaction was observed for some factors, such as age <55 vs. ≥55 and presence or absence of CVD, CHF, and DM. The cure rates for TGC pts were generally consistent across the subgroups, while those for LEV were more variable. Failure analysis revealed no significant risk factors for TGC pts, whereas multilobar disease, prior antibiotic failures, creatinine clearance (≤70 mL/min), and geographic region (Western Europe and US/Canada) were significant risk factors for LEV.

Conclusions: In both studies, TGC appeared safe and achieved cure rates similar to LEV in hospitalised pts with CAP. The cure rates for TGC pts were generally consistent across the subgroups. Further, in an analysis of risk factors, which contributed to failure of the study regimen, no prognostic factors were identified for TGC treated subjects.

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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