Moxifloxacin (Page 8 of 11)

14.3 Community Acquired Pneumonia

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 to 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 to 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 to 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 to 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 to 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.

Table 11: Clinical Success Rates By Pathogen (Pooled CAP Studies)

PATHOGEN Moxifloxacin
Streptococcus pneumoniae 80/85 (94%)
Staphylococcus aureus 17/20 (85%)
Klebsiella pneumoniae 11/12 (92%)
Haemophilus influenzae 56/61 (92%)
Chlamydophila pneumoniae 119/128 (93%)
Mycoplasma pneumoniae 73/76 (96%)
Moraxella catarrhalis 11/12 (92%)

Community Acquired Pneumonia caused by Multi-Drug Resistant Streptococcus pneumoniae (MDRSP)*

Moxifloxaxin was effective in the treatment of community acquired pneumonia (CAP) caused by multi-drug resistant Streptococcus pneumoniae MDRSP* 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.

* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant S.pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

Table 12: Clinical and Bacteriological Success Rates for Moxifloxacin-Treated MDRSP CAP Patients (Population: Valid for Efficacy)

Screening Susceptibility Clinical Success Bacteriological Success
n/Na % n/Nb %
Penicillin-resistant 21/21 100%c 21/21 100%c
2nd generation cephalosporin-resistant 25/26 96%c 25/26 96%c
Macrolide-resistantd 22/23 96% 22/23 96%
Trimethoprim/sulfamethoxazole-resistant 28/30 93% 28/30 93%
Tetracycline-resistant 17/18 94% 17/18 94%

a) n = number of patients successfully treated; N = number of patients with MDRSP (from a total of 37 patients)

b) n = number of patients successfully treated (presumed eradication or eradication); N = number of patients with MDRSP (from a total of 37 patients)

c) One patient had a respiratory isolate that was resistant to penicillin and cefuroxime but a blood isolate that was intermediate to penicillin and cefuroxime. The patient is included in the database based on the respiratory isolate.

d) Azithromycin, clarithromycin, and erythromycin were the macrolide antimicrobials tested.

Not all isolates were resistant to all antimicrobial classes tested. Success and eradication rates are summarized in Table 13.

Table 13: Clinical Success Rates and Microbiological Eradication Rates for Resistant Streptococcus pneumoniae (Community Acquired Pneumonia)

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 %)a 10/11 (90.9 %)a
Resistant to 4 antimicrobials 6/6 (100%) 6/6 (100%)
Resistant to 5 antimicrobials 7/7 (100%)a 7/7 (100%)a
Bacteremia with MDRSP 9/9 (100%) 9/9 (100%)

a) One patient had a respiratory isolate resistant to 5 antimicrobials and a blood isolate resistant to 3 antimicrobials. The patient was included in the category resistant to 5 antimicrobials.

14.4 Uncomplicated Skin and Skin Structure Infections

A randomized, double-blind, controlled clinical trial conducted in the US compared the efficacy of moxifloxacin 400 mg once daily for seven days with cephalexin HCl 500 mg three times daily for seven days. The percentage of patients treated for uncomplicated abscesses was 30%, furuncles 8%, cellulitis 16%, impetigo 20%, and other skin infections 26%. Adjunctive procedures (incision and drainage or debridement) were performed on 17% of the moxifloxacin treated patients and 14% of the comparator treated patients. Clinical success rates in evaluable patients were 89% (108/122) for moxifloxacin and 91% (110/121) for cephalexin HCl.

14.5 Complicated Skin and Skin Structure Infections

Two randomized, active controlled trials of cSSSI were performed. A double-blind trial was conducted primarily in North America to compare the efficacy of sequential intravenous/oral moxifloxacin 400 mg once a day for 7 to 14 days to an intravenous/oral beta-lactam/beta-lactamase inhibitor control in the treatment of patients with cSSSI. This study enrolled 617 patients, 335 of which were valid for the efficacy analysis. A second open-label International study compared moxifloxacin 400 mg once a day for 7 to 21 days to sequential intravenous/oral beta-lactam/beta-lactamase inhibitor control in the treatment of patients with cSSSI. This study enrolled 804 patients, 632 of which were valid for the efficacy analysis. Surgical incision and drainage or debridement was performed on 55% of the moxifloxacin treated and 53% of the comparator treated patients in these studies and formed an integral part of therapy for this indication. Success rates varied with the type of diagnosis ranging from 61% in patients with infected ulcers to 90% in patients with complicated erysipelas. These rates were similar to those seen with comparator drugs. The overall success rates in the evaluable patients and the clinical success by pathogen are shown in Tables 14 and 15.

Table 14: Overall Clinical Success Rates in Patients with Complicated Skin and Skin Structure Infections

Study Moxifloxacin n/ N (%) Comparator n/N (%) 95% Confidence Intervala
North America 125/162 (77.2%) 141/173 (81.5%) (-14.4%, 2%)
International 254/315 (80.6%) 268/317 (84.5%) (-9.4%, 2.2%)

a) of difference in success rates between Moxifloxacin and comparator (Moxifloxacin – comparator)

Table 15: Clinical Success Rates by Pathogen in Patients with Complicated Skin and Skin Structure Infections

Pathogen Moxifloxacin n/ N (%) Comparator n/N (%)
Staphylococcus aureus (methicillin-susceptible isolates)a 106/129 (82.2%) 120/137 (87.6%)
Escherichia coli 31/38 (81.6 %) 28/33 (84.8 %)
Klebsiella pneumoniae 11/12 (91.7 % ) 7/10 (70%)
Enterobacter cloacae 9/11 (81.8%) 4/7 (57.1%)

a) methicillin susceptibility was only determined in the North American Study

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