In a controlled double-blind study conducted in the US, Moxifloxacin Tablets (400 mg once daily for ten days) were compared with cefuroxime axetil (250 mg twice daily for ten days) for the treatment of acute bacterial sinusitis. The trial included 457 patients valid for the efficacy analysis. Clinical success (cure plus improvement) at the 7 to 21 day post-therapy test of cure visit was 90% for moxifloxacin and 89% for cefuroxime.
An additional non-comparative study was conducted to gather bacteriological data and to evaluate microbiological eradication in adult patients treated with moxifloxacin 400 mg once daily for seven days. All patients (n = 336) underwent antral puncture in this study. Clinical success rates and eradication/presumed eradication rates at the 21 to 37 day follow- up visit were 97% (29 out of 30) for Streptococcus pneumoniae , 83% (15 out of 18) for Moraxella catarrhalis , and 80% (24 out of 30) for Haemophilus influenzae.
Moxifloxacin Tablets (400 mg once daily for five days) were evaluated for the treatment of acute bacterial exacerbation of chronic bronchitis in a randomized, double-blind, controlled clinical trial conducted in the US. This study compared moxifloxacin with clarithromycin (500 mg twice daily for 10 days) and enrolled 629 patients. Clinical success was assessed at 7-17 days post-therapy. The clinical success for moxifloxacin was 89% (222/250) compared to 89% (224/251) for clarithromycin.
|Streptococcus pneumoniae||16/16 (100%)||20/23 (87%)|
|Haemophilus influenzae||33/37 (89%)||36/41 (88%)|
|Haemophilus parainfluenzae||16/16 (100%)||14/14 (100%)|
|Moraxella catarrhalis||29/34 (85%)||24/24 (100%)|
|Staphylococcus aureus||15/16 (94%)||6/8 (75%)|
|Klebsiella pneumoniae||17/20 (85%)||10/11 (91%)|
The microbiological eradication rates (eradication plus presumed eradication) in moxifloxacin treated patients were Streptococcus pneumoniae 100%, Haemophilus influenzae 89%, Haemophilus parainfluenzae 100%, Moraxella catarrhalis 85%, Staphylococcus aureus 94%, and Klebsiella pneumoniae 85%.
A randomized, double-blind, controlled clinical trial was conducted in the US to compare the efficacy of Moxifloxacin Tablets (400 mg once daily) to that of high-dose clarithromycin (500 mg twice daily) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 474 patients (382 of whom were valid for the efficacy analysis conducted at the 14–35 day follow-up visit). Clinical success for clinically evaluable patients was 95% (184/194) for moxifloxacin and 95% (178/188) for high dose clarithromycin.
A randomized, double-blind, controlled trial was conducted in the US and Canada to compare the efficacy of sequential intravenous/oral moxifloxacin 400 mg once a day for 7–14 days to an intravenous/oral fluoroquinolone control (trovafloxacin or levofloxacin) in the treatment of patients with clinically and radiologically documented community acquired pneumonia. This study enrolled 516 patients, 362 of whom were valid for the efficacy analysis conducted at the 7-30 day post-therapy visit. The clinical success rate was 86% (157/182) for moxifloxacin therapy and 89% (161/180) for the fluoroquinolone comparators.
An open-label ex-US study that enrolled 628 patients compared moxifloxacin to sequential intravenous/oral amoxicillin/clavulanate (1.2 gram intravenously every 8 hours/625 mg orally every 8 hours) with or without high-dose intravenous/oral clarithromycin (500 mg twice a day). The intravenous formulations of the comparators are not FDA approved. The clinical success rate at Day 5–7 for moxifloxacin therapy was 93% (241/258) and demonstrated superiority to amoxicillin/clavulanate ± clarithromycin (85%, 239/280) [95% C.I. of difference in success rates between moxifloxacin and comparator (2.9%, 13.2%)]. The clinical success rate at the 21–28 days post-therapy visit for moxifloxacin was 84% (216/258), which also demonstrated superiority to the comparators (74%, 208/280) [95% C.I. of difference in success rates between moxifloxacin and comparator (2.6%, 16.3%)].
The clinical success rates by pathogen across four CAP studies are presented in Table 11.
Community Acquired Pneumonia caused by Multi-Drug Resistant Streptococcus pneumoniae (MDRSP) 2
Moxifloxacin was effective in the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant Streptococcus pneumoniae MDRSP 2 isolates. Of 37 microbiologically evaluable patients with MDRSP isolates, 35 patients (95%) achieved clinical and bacteriological success post-therapy. The clinical and bacteriological success rates based on the number of patients treated are shown in Table 12.
|Screening Susceptibility||Clinical Success||Bacteriological Success|
|n/N *||%||n/N †||%|
|Penicillin-resistant||21/21||100% ‡||21/21||100% ‡|
|2 nd generation cephalosporin-resistant||25/26||96% ‡||25/26||96% ‡|
Not all isolates were resistant to all antimicrobial classes tested. Success and eradication rates are summarized in Table 13.
|S. pneumoniae with MDRSP||Clinical Success||Bacteriological Eradication Rate|
|Resistant to 2 antimicrobials||12/13 (92.3 %)||12/13 (92.3 %)|
|Resistant to 3 antimicrobials||10/11 (90.9 %) *||10/11 (90.9 %) *|
|Resistant to 4 antimicrobials||6/6 (100%)||6/6 (100%)|
|Resistant to 5 antimicrobials||7/7 (100%) *||7/7 (100%) *|
|Bacteremia with MDRSP||9/9 (100%)||9/9 (100%)|
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