Moxifloxacin Hydrochloride (Page 9 of 12)

14.4 Uncomplicated Skin and Skin Structure Infections

A randomized, double-blind, controlled clinical trial conducted in the U.S. compared the efficacy of moxifloxacin 400 mg once daily for seven days with cephalexin hydrochloride 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 hydrochloride treated patients and 14% of the comparator treated patients. Clinical success rates in evaluable patients were 89% (108/122) for moxifloxacin hydrochloride and 91% (110/121) for cephalexin hydrochloride.

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 hydrochloride 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
a) of difference in success rates between Moxifloxacin and comparator (Moxifloxacin – comparator)
Study Moxifloxacin Hydrochloride 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%)
Table 15: Clinical Success Rates by Pathogen in Patients with Complicated Skin and Skin Structure Infections
a) methicillin susceptibility was only determined in the North American Study
Pathogen Moxifloxacin Hydrochloride 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%)

14.6 Complicated Intra-Abdominal Infections

Two randomized, active controlled trials of cIAI 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 5 to 14 days to intravenous/piperacillin/tazobactam followed by oral amoxicillin/clavulanic acid in the treatment of patients with cIAI, including peritonitis, abscesses, appendicitis with perforation, and bowel perforation. This study enrolled 681 patients, 379 of which were considered clinically evaluable. A second open-label international study compared moxifloxacin 400 mg once a day for 5 to 14 days to intravenous ceftriaxone plus intravenous metronidazole followed by oral amoxicillin/clavulanic acid in the treatment of patients with cIAI. This study enrolled 595 patients, 511 of which were considered clinically evaluable. The clinically evaluable population consisted of subjects with a surgically confirmed complicated infection, at least 5 days of treatment and a 25 to 50 day follow-up assessment for patients at the Test of Cure visit. The overall clinical success rates in the clinically evaluable patients are shown in Table 16.

Table 16: Clinical Success Rates in Patients with Complicated Intra-Abdominal Infections
Study Moxifloxacin Hydrochloride n/N (%) Comparator n/N (%) 95% Confidence Intervala
a) of difference in success rates between moxifloxacin hydrochloride and comparator (moxifloxacin hydrochloride – comparator) b) Excludes 2 patients who required additional surgery within the first 48 hours. c) NA — not applicable
North America (overall) 146/183 (79.8%) 153/196 (78.1%) (-7.4%, 9.3%)
Abscess 40/57 (70.2%) 49/63 (77.8%)b NAc
Non-abscess 106/126 (84.1%) 104/133 (78.2%) NA
International (overall) 199/246 (80.9%) 218/265 (82.3%) (-8.9%, 4.2%)
Abscess 73/93 (78.5%) 86/99 (86.9%) NA
Non-abscess 126/153 (82.4%) 132/166 (79.5%) NA

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