1. Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Complicated Intraabdominal Infections
- Author
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Osvaldo Malafaia, Kyuran A. Choe, Vilas Satishchandran, Joseph S. Solomkin, Nicolas V. Christou, Hedy Teppler, Alexandra D. Carides, Ori D. Rotstein, E. Patchen Dellinger, Jose M. Tellado, Albert E. Yellin, and Alvaro Fernandez
- Subjects
Adult ,Ertapenem ,Male ,medicine.medical_specialty ,Abdominal Abscess ,Adolescent ,Lactams ,medicine.drug_class ,Antibiotics ,Penicillanic Acid ,Peritonitis ,beta-Lactams ,Tazobactam ,chemistry.chemical_compound ,Double-Blind Method ,medicine ,Humans ,Prospective Studies ,Intensive care medicine ,Digestive System Surgical Procedures ,Gram-Positive Bacterial Infections ,Aged ,Antibacterial agent ,Aged, 80 and over ,Piperacillin ,business.industry ,Original Articles ,Middle Aged ,Antimicrobial ,Anti-Bacterial Agents ,Hospitalization ,Piperacillin, Tazobactam Drug Combination ,Treatment Outcome ,chemistry ,Research Design ,Piperacillin/tazobactam ,Drug Therapy, Combination ,Female ,Surgery ,Anaerobic bacteria ,Gram-Negative Bacterial Infections ,business ,medicine.drug - Abstract
Complicated intraabdominal infections (i.e., those requiring both operative drainage and antimicrobial therapy) are among the most common infections in general surgery. Antimicrobial therapy is an important element in the management of these infections; there are convincing data that absent or inadequate empiric antibiotic therapy results in both increased failure rates and increased mortality. 1–4 The infecting flora seen with community-acquired intraabdominal infections is well known and consists of aerobic, facultative, and anaerobic gram-negative bacilli, various streptococci and enterococci, and a plethora of gram-positive anaerobes. 5–7 The synergistic interactions between endotoxin-bearing gram-negative organisms and Bacteroides fragilis define both groups as important targets for antimicrobial therapy. 8 Ertapenem (formerly MK-0826, Merck & Co., Inc.) is being investigated as a once-a-day parenteral β-lactam antimicrobial agent with the potential for use as monotherapy for the treatment of community-acquired mixed flora infections. This approach is based on its spectrum of activity, previously reported clinical studies that used once-a-day dosing, pharmacodynamic studies in animals, and pharmacokinetic studies in both humans and animals. 9,10 Ertapenem is highly active in vitro against gram-positive and gram-negative aerobic, facultative, and anaerobic bacteria, including the predominant pathogens responsible for intraabdominal infections. 11–13 However, it provides limited coverage against Pseudomonas aeruginosa, Acinetobacter spp, and enterococci, organisms generally associated with nosocomial infections. The primary objectives of this study were to determine the clinical and microbiologic efficacy and safety of ertapenem for patients with complicated intraabdominal infections. The comparative agent was piperacillin/tazobactam, a β-lactam/β-lactamase inhibitor combination agent that has been well studied and is approved in the treatment of intraabdominal infection. 14 This agent is typically administered at 3.375 g every 6 hours in the United States. This study also provided an opportunity to analyze an additional element of clinical trial design, the adequacy of surgical source control. Inadequate control of infection, through either incomplete drainage or incomplete management of enteric perforations, is an independent risk factor for treatment failure. 15,16 An expert panel review process was conducted to examine, under blinded conditions, the adequacy of surgical source control as a component of evaluability in a prospectively generated and well-documented group of patients.
- Published
- 2003
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