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Levofloxacin for Ventilator-Associated Pneumonia

Walter Reed Army Medical Center, Potomac, MD

PURPOSE: Nosocomial pneumonia (NP) remains a significant challenge in the ICU. Most clinical trials in this area have focused on non-ventilated patients with hospital-acquired pneumonia. Few studies have included individuals with ventilator-associated pneumonia (VAP). We describe the results for patients with VAP participating in a recent randomized trial comparing levofloxacin (L) to imipenem/cilistatin (I).

METHODS: In this multicenter, randomized, controlled trial, subjects with NP were treated with either L 750 mg q24 h or I 500 – 1000 mg q6-8h. Both combination therapy with additional anti-pseudomonal agents in cases of known or suspected P. aeruginosa and the use of vancomycin were permitted. Patients with VAP were defined as those receiving at least 48 hours of mechanical ventilation (MV) before developing pneumonia. Clinical success (either clinical cure or improvement) represented the primary endpoint. Mortality at follow-up evaluation (28-32 days post-therapy) served as a secondary endpoint.

RESULTS: The entire NP cohort included 438 patients of which 222 (50.7%) had VAP. The most frequently isolated gram negative pathogens included: P. aeruginosa (n=36), E. coli (n=19), and K. pneumoniae (n=17). Patients treated with L (n=111) were comparable to those receiving I (n=111): mean age 52.2±20.9 yrs. for L vs 53.5±21.6 yrs. for I, (p=.65); mean APACHE II 14.8±5.2 with L vs. 15.1±5.4 for I, (p=.88). Neither duration of MV prior to developing VAP (8.0±7.3 days with L vs. 9.8±18.2 days with I, p=.31) nor need for vasopressors (17.1% with L vs. 12.6% with I, p=.35) differed based on initial antibiotic regimen. Outcome results are shown in the table

L I P-value ITT*, clinical success 58.6% 63.1% .49 Clinically evaluable cohort#, success 56.1% 58.1% .82 Mortality 11.0% 13.1% .68

^* ITT – intention to treat;

^# Clinically evaluable – received at least 5 days of study therapy

below.

CONCLUSIONS: L is as effective as I for the empiric treatment of VAP.

CLINICAL IMPLICATIONS: Levofloxacin (750 mg q24h) represents an effective, once daily alternative for therapy in critically ill patients with VAP.

DISCLOSURE: A.F. Shorr, OMP, Grant monies.