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

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.

Impact of a diabetes disease management program on diabetes control and patient quality of life.

The worldwide burden of diabetes is projected to be 5.4% of the adult population by the year 2025. Diabetes is associated with multiple medical complications that both decrease health-related quality of life (HR-QOL) and contribute to earlier mortality. There is growing evidence for the effectiveness of multidisciplinary disease management programs that incorporate self-management principles in improving patients' long-term outcomes. The aim of this project was to evaluate the effectiveness of this approach in improving: (1) glycemic control measured by HbA1c, and (2) HR-QOL measured by the Assessment of Quality of Life (AQOL), at enrollment and at 12-months follow-up. Between 2004 and 2008, a total of 967 patients were enrolled in the program; 545 (56%) of these patients had HbA1c data available at baseline and at 12 months. Mean HbA1c at enrollment was 8.6% (SD 1.9) versus 7.3% (SD 1.2) at 12 months (P<0.001). Overall, 68% of patients experienced improvements in HbA1c. At enrollment, patients reported "fair" HR-QOL, which was significantly lower than age-adjusted population norms who reported "good" HR-QOL. At 12 months, 251 (64%) patients had improved HR-QOL, 27 (7%) had no change, and 114 (29%) deteriorated. Mean utility scores improved by 0.11 (P<0.001), which is almost twice the minimum clinically important difference for the AQOL. This study confirms that a multidisciplinary disease management program for patients with poorly controlled type 2 diabetes can improve both glycemic control and HR-QOL.