Gatifloxacin in the treatment of community-acquired pneumonias: a comparative trial of ceftriaxone, with or without macrolides, in hospitalized adult patients with mild to moderately severe pneumonia

Community-acquired pneumonia is very common, but some of the cases do require hospitalization for treatment, particularly when older patients and/or co-morbidities are involved; both "typical" and "atypical" respiratory pathogens take part etiologically, and there is increasing concern about the emergence of resistance. There is interest in therapeutic options that can: a) comprehend such a spectrum of bacteria and resistance; b) allow parenteral to oral sequential treatment. We made a multicenter, prospective and randomized trial to compare the "standard" treatment of ceftriaxone IV alone or in combination with erythromycin IV, followed by clarithromycin PO (ceftriaxone treatment arm), with gatifloxacin IV, followed by oral administration (gatifloxacin treatment arm). The need for hospitalization was based on clinical criteria as judged by the investigators. Standardized criteria for diagnosis and follow-up were employed. Fifty-six patients were enrolled, with 48% over 65 years old, and there were frequent co-morbidities. Of these, 51 were clinically evaluable, 26 in the gatifloxacin and 25 in the ceftriaxone arm, with comparable success rates, 92% and 88%, respectively, even when major prognostic factors were considered. There were no serious adverse events or significant laboratory value changes attributable to the study drugs. Gatifloxacin as monotherapy (initially IV then orally until completion of treatment) was shown to be effective and safe, comparable to ceftriaxone IV alone or in combination with a macrolide (initially IV then orally until completion of treatment), in empirical therapy for community-acquired pneumonias, for patients that, at the physician s discretion, require initial treatment as inpatients