Antibiotic Therapy for Diabetic Foot Infections: Comparison of Two Parenteral-to-Oral Regimens

Abstract

This prospective, randomized, multicenter trial compared the efficacy of two antibiotic regimens for treatment of foot infections in diabetic adults. Patients with infections requiring hospitalization were randomized to receive either intravenous ofloxacin followed by oral ofloxacin or intravenous ampicillin/sulbactam followed by oral amoxicillin/clavulanate (the aminopenicillin regimen) for 14-28 days. Patients with osteomyelitis were eligible for the study if the infected bone was to be removed. Of 108 patients enrolled in the study, 88 who were evaluable had various skin and softtissue infections, and 24% had osteomyelitis. For the ofloxacin and aminopenicillin regimens, the mean duration of intravenous therapy was 7.8 and 7.1 days, respectively, the mean duration of oral therapy was 13.2 and 12.0 days, respectively, the rate of eradication of pathogens was 78% and 88%, respectively, and the overall rate of clinical cure or improvement was 85% and 83%, respectively. Thus, about 3 weeks of therapy with either regimen was well tolerated and effective in treating these diabetic foot infections.Lower-extremity infections are a frequent problem in diabetic patients and are now the most common cause of hospitalization [1][2][3][4]. Although some patients can be treated exclusively as outpatients, most are hospitalized initially for diagnostic studies and parenteral antibiotic therapy. In the past two decades, studies have helped to define the etiologic agents of these infections [1], but there have been surprisingly few investigations of antimicrobial therapy [1][2][3].Among the previously published reports on the efficacy of antibiotic therapy for diabetic foot infections, only four were randomized, controlled trials: one exclusively enrolled outpatients with relatively mild infections [4], two involved hospitalized patients with peripheral vascular disease [5,6], and one included only patients with limb-threatening infections [7].A variety of antibiotics, ranging from narrow-spectrum oral agents to broad-spectrum parenteral agents, were employed. Thus, few data are available to help clinicians determine the optimal choice of antimicrobial(s), the need for parenteral vs. oral agents, and the duration of therapy required for these infections. To address these issues, we conducted a prospective, Received 30 May 1996; revised 7 November 1996. Informed consent was obtained from the patients, and the guidelines for human experimentation of the U.S. Department of Health and Human Services and the authors' institutions were followed in the conduct of this clinical research.Financial randomized, multicenter study of the efficacy of two relatively broad-spectrum therapeutic regimens administered parenterally initially and then orally. MethodsPatients who had diabetes mellitus and a foot infection that required antibiotic therapy, as evidenced by purulent drainage, erythema, and swelling, and who were 18 years of age or older were potentially eligible for enrollment in the study. Patients were initially hospitalized usually...

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

“…ampicillin-sulbactam (1 to 2 g and 0.5 to 1 g) followed by p.o. amoxicillin-clavulanate (500 and 125 mg) in the treatment of diabetic patients hospitalized with foot infections; clinical success rates (cure and improvement) were 85% in the ofloxacin group and 83% in the aminopenicillin group, and microbiological eradication rates were 78 and 88%, respectively (26).…”

Diabetic foot osteomyelitis: a progress report on diagnosis and a systematic review of treatment

“…Published studies variously reported treatment with intravenous [4] or oral antimicrobials [48,50], or shortduration intravenous followed by oral therapy [55]. A single randomized study compared results with oral and intravenous antibiotics [52].…”

A report from the international consensus on diagnosing and treating the infected diabetic foot

“…On the basis of available studies, for mild to moderate infections, 1 to 2 weeks is usually effective [16], while for more serious infections, 2 to 4 weeks is usually sufficient [48,49]. A longer duration may be needed for immunocompromised patients, poorly perfused, deep, large or necrotic wounds, or osteomyelitis (vide infra).…”