Efficacy and tolerability of moxifloxacin in the treatment of acute bacterial sinusitis caused by penicillin-resistant streptococcus pneumoniae: A pooled analysis

Abstract

Background: Penicillin-resistant Streptococcus pneumoniae (PRSP) has become a relatively common pathogen in upper and lower respiratory tract infections, including acute bacterial sinusitis (ABS). Objective: The goal of this analysis was to assess the efficacy and tolerability of moxifloxacin in the treatment of ABS caused by penicillin-sensitive S pneumoniae (PSSP) and PRSP Methods: Two prospective, multicenter, open-label, noncomparative US trials of moxifloxacin were included in this pooled analysis. All patients received oral moxifloxacin 400 mg once daily for 7 to 10 days. Minimum inhibitory concentrations (MICs) of moxifloxacin and penicillin were determined using the E-test and standard broth-microdilution methods. The primary end point was clinical success at the test-of-cure visit (21–37 days after completion of therapy) in patients with a positive pretherapy sinus culture. Data are presented for patients with ABS caused by both PSSP and PRSP Results: Of 806 patients enrolled in the 2 studies, 146 had microbiologically confirmed bacterial infection. Sixty-nine patients had ABS caused by S pneumoniae, including 15 confirmed cases of PRSP infection. The majority of the 69 clinically evaluable patients were white (n = 63) and female (n = 46), and the mean age of this population was 43 years. Investigators categorized the episode of ABS as severe in 26 (37.7%) of clinically evaluable patients and of moderate severity in the remainder (62.3% [43]); however, most patients (78.3% [54/69]) reported ≥1 severe symptom. The episode of ABS was classified as severe in 8 (53.3%) of the 15 patients with PRSP infection. Clinical and bacteriologic success at the test-of-cure visit was achieved in 93.3% (14/15) of patients with PRSP infection, compared with 88.4% (61/69) of all patients infected with S pneumoniae regardless of penicillin susceptibility. Moxifloxacin MICs against the 15 PRSP strains ranged from 0.06 to 0.25 μg/mL. Data from 805 patients were available for tolerability analysis. The most commonly occurring adverse events were nausea, headache, and diarrhea. Generally, adverse events were mild to moderate. None of the 6 serious adverse events reported were considered related to moxifloxacin therapy. Conclusion: In this small cohort of patients, moxifloxacin provided clinical and bacteriologic cures in the majority of patients with ABS caused by PRSP, including those with severe sinusitis.