Oral versus parenteral antimicrobials for the treatment of cellulitis: A randomized non-inferiority trial

Abstract

Objectives: To determine whether outcomes for patients with cellulitis treated with oral antimicrobials are as good as for those who are treated with parenteral antimicrobials. Methods: A prospective randomized non-inferiority trial was conducted at a tertiary teaching hospital in Melbourne, Australia. Participants were patients referred by the emergency department for treatment of uncomplicated cellulitis with parenteral antimicrobials. Patients were randomized to receive either oral cefalexin or parenteral cefazolin. Parenteral antimicrobials were changed to oral after the area of cellulitis ceased progressing. The primary outcome was days until no advancement of the area of cellulitis. A non-inferiority margin of 15% was set for the oral arm compared with the parenteral arm. Secondary outcomes were failure of treatment, pain, complications and satisfaction with care. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000685910). Results: Twenty-four patients were randomized to oral antimicrobials and 23 to parenteral antimicrobials. Mean days to no advancement of cellulitis was 1.29 (SD 0.62) for the oral arm and 1.78 (SD 1.13) for the parenteral arm, with a mean difference of -0.49 (95% CI: -1.02 to +0.04). The upper limit of the 95% CI of the difference in means of +0.04 was below the 15% non-inferiority margin of +0.27 days, indicating non-inferiority. More patients failed treatment in the parenteral arm (5 of 23, 22%) compared with the oral arm (1 of 24, 4%), although this difference was not statistically significant (P=0.10). Pain, complications and satisfaction with care were similar for both groups. Conclusions: Oral antimicrobials are as effective as parenteral antimicrobials for the treatment of uncomplicated cellulitis.