title: Clinafloxacin versus piperacillin-tazobactam in treatment of patients with severe skin and soft tissue infections.
abstract: Patients (n = 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens. Fewer baseline pathogens were resistant to clinafloxacin (1.8%) than to piperacillin-tazobactam (6.2%) (P = 0.001). The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates (68.8 and 65.2%, respectively) or microbiologic eradication rates (61.5 and 57.2%). Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species, although no differences were statistically significant. Within the power of this study, the overall frequency of adverse events was similar (P = 0.577) in the two treatment groups. Drug-associated adverse events (P = 0.050) and treatment discontinuations (P = 0.052) were marginally more frequent in the clinafloxacin group, primarily due to phototoxicity in outpatients receiving clinafloxacin. Although most cases of phototoxicity were mild to moderate, four cases were reported as severe. In summary, clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs.
authors.affiliation: Vanderbilt University VA Medical Center, Nashville, Tennessee.
authors.forename: G
authors.initials: G
authors.lastname: Siami
authors.forename: N
authors.initials: N
authors.lastname: Christou
authors.forename: I
authors.initials: I
authors.lastname: Eiseman
authors.forename: K J
authors.initials: KJ
authors.lastname: Tack
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000627:therapeutic use; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use*; D010878:Piperacillin / Q000009:adverse effects / Q000627:therapeutic use*; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000382:microbiology; D000078142:Tazobactam; D065093:beta-Lactamase Inhibitors
chemical_list: D000890:Anti-Infective Agents; D004791:Enzyme Inhibitors; D024841:Fluoroquinolones; D010406:Penicillins; D065093:beta-Lactamase Inhibitors; D010397:Penicillanic Acid; C057477:clinafloxacin; D000078142:Tazobactam; D010878:Piperacillin