Risk factors leading to clinical failure in the treatment of intra-abdominal or skin/soft tissue infections.

A study of determinants of outcome in adult patients with intra-abdominal or skin/soft tissue infections treated with cefotetan, cefoxitin, or ampicillin/sulbactam monotherapy was undertaken. Patients were matched for principal infectious process, surgery performed for the management of the infection, year of hospital admission, age, and sex. The criteria for inclusion, exclusion, and matching of patients and assignment of clinical and microbiological outcome were based on the 1992 Infectious Diseases Society of America/Federal Drug Administration guidelines for the evaluation of anti-infective drug products. One hundred and thirty-seven cases of intra-abdominal or skin and soft tissue infections treated with cefotetan (n = 47), cefoxitin (n = 43), or ampicillin/sulbactam (n = 47) monotherapy were selected without knowledge of outcome and analyzed using a single blinded analysis. The baseline characteristics did not differ between the treatment groups, nor did the rates of clinical or microbiological failure. A multivariate analysis showed that isolation of an organism resistant to the treatment regimen, including Pseudomonas spp., [odds ratio (OR) = 14.9, p = 0.001], being on antibiotic therapy at the time of admission (OR = 4.5, p = 0.007), and diagnosis of a complicated intra-abdominal infection (OR = 3.5, p = 0.014) were independently associated with clinical failure. These data support the assertion that antibiotic resistant organisms in mixed anaerobic/aerobic infections are associated with clinical failure and suggest that the antibiotic regimen should be modified to include Pseudomonas spp. in its spectrum when this organism is isolated from patients with such infections.