Evaluation of outpatient treatment with ertapenem in a double blind controlled clinical trial of complicated skin/skin structure infections

• Published in: The Journal of infection 2004, Vol.48 (1), p.32-38
• Main Authors: Gesser, Richard M, McCarroll, Kathleen A, Woods, Gail L
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; beta-Lactams; Biological and medical sciences; Chi-Square Distribution; Complicated skin infections; Double-Blind Method; Drug Therapy, Combination - therapeutic use; Enzyme Inhibitors - therapeutic use; Ertapenem; Female; Humans; Infectious diseases; Infusions, Intravenous; Lactams - therapeutic use; Logistic Models; Male; Medical sciences; Middle Aged; Outpatient antimicrobial therapy; Penicillanic Acid - analogs & derivatives; Penicillanic Acid - therapeutic use; Pharmacology. Drug treatments; Piperacillin - therapeutic use; Prospective Studies; Skin Diseases - drug therapy; Skin Diseases - microbiology; Statistics, Nonparametric; Tazobactam; Treatment Outcome
• ISSN: 0163-4453; 1532-2742
• DOI: 10.1016/j.jinf.2003.10.001

Objectives. The patient characteristics and the efficacy and safety of ertapenem 1 g once daily vs. piperacillin-tazobactam 13.5 g divided Q6H were examined in patients who received outpatient parenteral antimicrobial therapy (OPAT) during a clinical trial of complicated skin/skin structure infections. Methods. The population analyzed included 363 patients treated at US sites in a large randomized double-blind study. Results. In this analysis, 146 (40%) patients at 19 (66%) sites were managed by OPAT. A lower proportion of treated patients who received OPAT had severe infection (12% vs. 20%, P=0.03). In evaluable patients managed by OPAT, 45 (83.3%) of 54 treated with ertapenem and 41 (82.0%) of 50 treated with piperacillin-tazobactam were cured at the test of cure assessment 10–21 days post-therapy (OR 1.2 (95% CI, 0.4–3.2), P=0.78). The safety profile of both drugs was generally similar; diarrhoea was the most common adverse event in both groups. Conclusions. In this trial of complicated skin/skin structure infection, OPAT was commonly used by US investigators. Among patients who received OPAT, ertapenem 1 g daily was as effective as piperacillin-tazobactam 3.375 g Q6H.