کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6115778 1215928 2014 12 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis
ترجمه فارسی عنوان
مطالعه فاز 3 در مقایسه با تیگ اکیکلین و ارتاپنم در بیماران مبتلا به عفونت های پا دیابتی با و بدون استئومیلیت
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی میکروبیولوژی و بیوتکنولوژی کاربردی
چکیده انگلیسی
A phase 3, randomized, double-blind trial was conducted in subjects with diabetic foot infections without osteomyelitis (primary study) or with osteomyelitis (substudy) to determine the efficacy and safety of parenteral (intravenous [iv]) tigecycline (150 mg once-daily) versus 1 g once-daily iv ertapenem ± vancomycin. Among 944 subjects in the primary study who received ≥1 dose of study drug, >85% had type 2 diabetes; ~90% had Perfusion, Extent, Depth/tissue loss, Infection, and Sensation infection grade 2 or 3; and ~20% reported prior antibiotic failure. For the clinically evaluable population at test-of-cure, 77.5% of tigecycline- and 82.5% of ertapenem ± vancomycin-treated subjects were cured. Corresponding rates for the clinical modified intent-to-treat population were 71.4% and 77.9%, respectively. Clinical cure rates in the substudy were low (<36%) for a subset of tigecycline-treated subjects with osteomyelitis. Nausea and vomiting occurred significantly more often after tigecycline treatment (P = 0.003 and P < 0.001, respectively), resulting in significantly higher discontinuation rates in the primary study (nausea P = 0.007, vomiting P < 0.001). In the primary study, tigecycline did not meet criteria for noninferiority compared with ertapenem ± vancomycin in the treatment of subjects with diabetic foot infections.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Diagnostic Microbiology and Infectious Disease - Volume 78, Issue 4, April 2014, Pages 469-480
نویسندگان
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