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Abstract
BackgroundComplicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. The efficacy and safety of tigecycline, an expanded broad-spectrum glycylcycline antibiotic, was compared with imipenem/cilastatin (IMI/CIS) in patients with cIAI.MethodsA prospective, double-blind, multinational trial was conducted in which patients with cIAI randomly received intravenous (IV) tigecycline (100 mg initial dose, then 50 mg every 12 hours [q12h]) or IV IMI/CIS (500/500 mg q6h or adjusted for renal dysfunction) for 5 to14 days. Clinical response at the test-of-cure (TOC) visit (14–35 days after therapy) for microbiologically evaluable (ME) and microbiological modified intent-to-treat (m-mITT) populations were the co-primary efficacy endpoint populations.ResultsA total of 825 patients received ≥ 1 dose of study drug. The primary diagnoses for the ME group were complicated appendicitis (59%), and intestinal (8.8%) and gastric/duodenal perforations (4.6%). For the ME group, clinical cure rates at TOC were 80.6% (199/247) for tigecycline versus 82.4% (210/255) for IMI/CIS (95% CI -8.4, 5.1 for non-inferiority tigecycline versus IMI/CIS). Corresponding clinical cure rates within the m-mITT population were 73.5% (227/309) for tigecycline versus 78.2% (244/312) for IMI/CIS (95% CI -11.0, 2.5). Nausea (31.0% tigecycline, 24.8% IMI/CIS [P = 0.052]), vomiting (25.7% tigecycline, 19.4% IMI/CIS [P = 0.037]), and diarrhea (21.3% tigecycline, 18.9% IMI/CIS [P = 0.435]) were the most frequently reported adverse events.ConclusionThis study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI.
Highlights
Complicated intra-abdominal infections remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria
Treatment of complicated intra-abdominal infections remains a challenge, primarily because of their polymicrobial etiology coupled with the high risk of complications and death
The initial selection of antimicrobial therapy for treatment of intraabdominal infections is extremely important because inappropriate empiric antimicrobial therapy has been associated with delayed clinical resolution, increased length of hospital stay, and an increased risk of mortality [6,7]
Summary
Complicated intra-abdominal infections (cIAI) remain challenging to treat because of their polymicrobial etiology including multi-drug resistant bacteria. Complicated intra-abdominal infections are characterized as local or systemic infections secondary to a physical perforation in the gastrointestinal tract or via a necrotic gut wall into the peritoneal space, leading to abscess formation or peritonitis [1]. These infections require a combination of appropriate and timely surgical source control and broad spectrum antimicrobial therapy for optimal outcome. The recent 2003 guidelines of the Infectious Diseases Society of America (IDSA) advocates broad-spectrum single or combination therapy (eg, carbapenem or piperacillin/ tazobactam monotherapy, third- or fourth-generation cephalosporins or fluoroquinolones plus metronidazole) for high-risk patients with severe or postoperative nosocomial intra-abdominal infections wherein polymicrobial infection and/or resistant flora are more prevalent [1]. Adequate surgical source control is an important determinant of outcome; insufficient drainage and repair may compromise the effectiveness of antibiotic therapy [1]
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