Noncomparative trial of ticarcillin plus clavulanic acid in skin and soft tissue infections

Abstract

Ticarcillin, a broad-spectrum penicillin [l], is susceptible in inactivation by a number of beta-lactamases. Clavulanic acid, a naturally occurring beta-lactamase inhibitor, has been shown to prevent the enzymatic degradation of beta-lactam antibiotics by a number of bacterial species [2]. In vitro studies have shown that in combination, ticarcillin and clavulanic acid may be synergistic in activity [3,4]. In the current study, we evaluated the clinical efficacy and safety of this combination in hospitalized patients with skin and skin structure infections. PATIENTS AND METHODS Patient Population. This research protocol was approved by the Human Studies Committee at both Hahnemann University Hospital and St. Michael’s Medical Center. The 79 patients in this study were adults hospitalized at either of the just mentioned medical centers, and informed consent was obtained by the investigators from each patient who entered the study. Each patient had either an acute or chronic skin or skin structure infection caused by an organism or organisms known or suspected to be susceptible to the combination of ticarcillin plus clavulanic acid. Patients excluded from the study included: pregnant or lactating women; recipients of an antimicrobial agent within the previous 72 hours to which the pathogen was susceptible; subjects with a known hypersensitivity to penicillin; and patients with known moderate to severe renal or hepatic dysfunction. Laboratory Studies. The following laboratory determinations were made before, during, and after treatment with ticarcillin plus clavulanic acid: complete hemogram, prothrombin time, quantitative platelet count, direct Coombs’ test, alkaline phosphatase, bilirubin, serum glutamic oxalacetic transaminase, serum glutamic pyruvic transaminase, lactic dehydrogenase, serum concentrations of sodium, potassium, chloride, carbon dioxide, blood urea nitrogen, serum creatinine, blood glucose, and urinalysis. Blood, purulent exudates from wounds, pus from abscesses, and excised tissue were obtained before, during, and after antibiotic therapy for aero