| Autor: |
Oliva, María E., Rekha, Arcot, Yellin, Albert, Pasternak, Jacyr, Campos, Maria, Rose, Gilbert M., Babinchak, Timothy, Ellis-Grosse, Evelyn J., Loh, Evan |
| Předmět: |
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| Zdroj: |
BMC Infectious Diseases; 2005, Vol. 5 Issue 1, p88-12, 12p, 1 Diagram, 5 Charts |
| Abstrakt: |
Background: Complicated 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. Methods: A 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 (mmITT)populations were the co-primary efficacy endpoint populations. Results: A 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. Conclusion: This study demonstrates that tigecycline is as efficacious as imipenem/cilastatin in the treatment of patients with cIAI. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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