Randomized, open-label, parallel-group, multicenter study of the efficacy and tolerability of IV gatifloxacin with the option for oral stepdown gatifloxacin versus IV ceftriaxone (with or without erythromycin or clarithromycin) with the option for oral stepdown clarithromycin for treatment of patients with mild to moderate community-acquired pneumonia requiring hospitalization

Abstract

Background: Empiric therapy for community-acquired pneumonia (CAP) requires the use of antibiotics with activity against a broad spectrum of respiratory pathogens and suitable pharmacokinetic properties to simplify IV-to-oral step-down therapy switches. Objective: The aim of this study was to compare the efficacy and tolerability of IV gatifloxacin with the option for oral stepdown gatifloxacin with a standard regimen of IV ceftriaxone (with or without erythromycin or clarithromycin) with the option for oral stepdown clarithromycin in patients with mild to moderate CAP requiring hospitalization. Methods: In a randomized, open-label, parallel-group, multicenter study, adults with CAP received 7 to 14 days of treatment with either IV gatifloxacin 400 mg QD with the stepdown option or IV ceftriaxone 1 or 2 g QD (with or without erythromycin 0.5 or 1 g QID or clarithromycin 500 mg BID) with the stepdown option. Results: One hundred seventy adults with CAP were included in the study. IV gatifloxacin was stepped down to oral gatifloxacin in 90.6% (View the MathML source) of patients; IV ceftriaxone was stepped down to oral clarithromycin in 87.1% (View the MathML source) of patients. Among clinically evaluable patients (n = 153), cure rates at 1 to 3 days after treatment were 97.4% in the gatifloxacin group (View the MathML source) and 90.9% in the ceftriaxone group (View the MathML source), with a 95% CI for the difference (−3.7% to 19.1%) indicating statistical equivalence. In patients in whom pathogens were isolated from pretreatment sputum cultures, bacteriologic eradication rates were 100.0% (View the MathML source) and 90.9% (View the MathML source), respectively. Both regimens were well tolerated; treatment-related adverse events occurred in 27.1% (View the MathML source) and 21.2% (View the MathML source) of patients, respectively. Conclusions: In the population studied, treatment with IV gatifloxacin with an option for oral stepdown gatifloxacin was as effective for achieving clinical cure as IV ceftriaxone (with or without concomitant IV erythromycin or clarithromycin) with an option for oral stepdown clarithromycin. Both regimens were well tolerated.