- 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.
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.
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 7-14 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 7-21 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.
|Study||Moxifloxacin n/N (%)||Comparator n/N (%)||95% Confidence Interval *|
|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%)|
|Pathogen||Moxifloxacin n/ N (%)||Comparator n/N (%)|
|Staphylococcus aureus (methicillin-susceptible isolates) *||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%)|
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 5-14 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 5-14 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 25-50 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.
|Study||Moxifloxacin n/ N (%)||Comparator n/N (%)||95% Confidence Interval *|
|North America (overall)||146/183 (79.8%)||153/196 (78.1%)||(-7.4%, 9.3%)|
|Abscess||40/57 (70.2%)||49/63 (77.8%) †||NA ‡|
|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|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.