کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3347940 1215991 2009 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin ★
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی میکروبیولوژی و بیوتکنولوژی کاربردی
پیش نمایش صفحه اول مقاله
Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin ★
چکیده انگلیسی

Tigecycline exhibits potent in vitro activity against many community-acquired pneumonia (CAP) pathogens, including antibiotic-resistant ones. Its spectrum of activity and ability to penetrate lung tissue suggest it may be effective for hospitalized CAP patients. Hospitalized CAP patients (n = 418) were randomized to receive intravenous (IV) tigecycline or levofloxacin. Patients could be switched to oral levofloxacin after receiving 6 or more doses of IV study medication. Therapy duration was 7 to 14 days. Coprimary efficacy end points were clinical responses in the clinically evaluable (CE: tigecycline, n = 138; levofloxacin, n = 156) and clinical modified intent-to-treat (c-mITT: tigecycline, n = 191; levofloxacin, n = 203) populations at test-of-cure (TOC). Safety was assessed in the mITT population (tigecycline, n = 208; levofloxacin, n = 210). Cure rates in tigecycline and levofloxacin groups were comparable in CE (90.6% versus 87.2%, respectively) and c-mITT (78% versus 77.8%, respectively) populations at TOC. Nausea and vomiting occurred in significantly more tigecycline-treated patients; elevated alanine aminotransferase and aspartate aminotransferase levels were reported in significantly more levofloxacin-treated patients. There were no significant differences in hospital length of stay, median duration of IV or oral antibiotic treatments, hospital readmissions, or number of patients switched to oral levofloxacin. Tigecycline was safe, effective, and noninferior to levofloxacin in hospitalized patients with CAP.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Diagnostic Microbiology and Infectious Disease - Volume 63, Issue 1, January 2009, Pages 52–61
نویسندگان
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