NDLI: Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia.

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Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia.

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Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Tanaseanu, Cristina Bergallo, Carlos Teglia, Osvaldo Jasovich, Abel Oliva, Maria Eugenia Dukart, Gary Dartois, Nathalie Cooper, C. Angel Gandjini, Hassan Mallick, Rajiv
Description	Country affiliation: Romania Author Affiliation: Tanaseanu C ( Department of Internal Medicine, St. Pantelimon Clinical Emergency Hospital, Bucharest OP 22, Romania. cristina.tanaseanu@gmail.com)
Abstract	Tigecycline (TGC), a glycylcycline, has expanded activity against Gram-positive and Gram-negative, anaerobic, and atypical bacteria. Two phase 3 studies were conducted. Hospitalized patients with community-acquired pneumonia (CAP) were randomized to intravenous (IV) TGC (100 mg followed by 50 mg bid) or IV levofloxacin (LEV) (500 mg bid). In 1 study, patients could be switched to oral LEV after at least 3 days intravenously. The coprimary efficacy end points were as follows: clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure (TOC). The secondary end points were as follows: microbiologic efficacy and susceptibility to TGC for CAP bacteria. Safety evaluations were included. Eight hundred ninety-one were patients screened: 846 mITT (TGC 424, LEV 422), 574 CE (TGC 282, LEV 292). Most patients had Fine Pneumonia Severity Index II to IV (80.7% TGC, 74.4% LEV, mITT). At TOC (CE), TGC cured 253/282 patients (89.7%) and LEV cured 252/292 patients (86.3%); the absolute difference of TGC-LEV was 3.4% (95% confidence interval [CI], -2.2 to 9.1, noninferior [P < 0.001]). In c-mITT, TGC cured 319/394 patients (81.0%) and LEV cured 321/403 patients (79.7%); the absolute difference of TGC-LEV was 1.3% (95% CI -4.5 to 7.1, noninferior [P < 0.001]). The drug-related adverse events (AEs) of nausea (20.8% TGC versus 6.6% LEV) and vomiting (13.2% TGC versus 3.3% LEV) were significantly higher in TGC; elevated alanine aminotransferase (2.8% TGC versus 7.3% LEV) and aspartate aminotransferase (2.6% TGC versus 6.9% LEV) were significantly higher in LEV. Discontinuations for AEs were low (TGC, 26 patients [6.1%]; LEV, 34 patients [8.1%]). TGC appeared safe and achieved cure rates similar to LEV in hospitalized patients with CAP.
File Format	HTM / HTML
ISSN	07328893
Issue Number	3
Volume Number	61
e-ISSN	18790070
Journal	Diagnostic Microbiology and Infectious Disease
Language	English
Publisher	Elsevier
Publisher Date	2008-07-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Microbiology Discipline Communicable Diseases Anti-bacterial Agents Therapeutic Use Community-acquired Infections Drug Therapy Levofloxacin Minocycline Analogs & Derivatives Ofloxacin Pneumonia, Bacterial Adult Aged Administration & Dosage Adverse Effects Female Gram-negative Bacterial Infections Haemophilus Infections Humans Liver Function Tests Male Middle Aged Pneumococcal Infections Treatment Outcome Clinical Trial, Phase Iii Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Infectious Diseases Microbiology (medical)

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