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Antimicrobial Agents and Chemotherapy, February 2001, p. 525-531, Vol. 45, No. 2
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.2.525-531.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

G. Siami,1,dagger N. Christou,2,dagger I. Eiseman,3,* K. J. Tack,3 and the Clinafloxacin Severe Skin And Soft Tissue Infections Study Groupdagger

Vanderbilt University VA Medical Center, Nashville, Tennessee1 McGill University Health Centre, Montreal, Quebec, Canada2; and Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan3

Received 13 March 2000/Returned for modification 18 August 2000/Accepted 25 October 2000

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.

* Corresponding author. Mailing address: Parke-Davis Pharmaceutical Research, Ann Arbor, MI 48105. Phone: (734) 622-7333. Fax: (734) 622-1333. E-mail: irene.eiseman{at}wl.com.

dagger Member of the Clinafloxacin Severe Skin and Soft Tissue Infection Study Group. Additional members of the Clinafloxacin Severe Skin and Soft Tissue Infections Study Group are listed in the appendix.

Antimicrobial Agents and Chemotherapy, February 2001, p. 525-531, Vol. 45, No. 2
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.2.525-531.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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