1 Antibacterial treatment effect estimation in acute bacterial skin and
May 18, 2015 ... tissue infection (cSSTI), complicated skin and skin structure infection (cSSSI), treatment effect,. 46 abscess ... with ABSSSI in a global phase 3 clinical development program. ... skin structure infections (cSSSI). ... clinical trials reporting a placebo treatment response in uncomplicated skin and soft tissue. 93 ...
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Systematic Review and Meta-Analysis To Estimate Antibacterial
Apr 30, 2015 ... Treatment Effect in Acute Bacterial Skin and Skin Structure Infection ... previously referred to as complicated skin and skin structure in- ... for hospitalized adults with ABSSSI in a global phase 3 clinical ... tions (cSSSI) were included. ... include clinical trials reporting a placebo treatment response in uncom-.
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Infections Complicated Skin and Skin Structure Standard Therapy in
Adults with cSSSI, including at least one systemic marker of inflammation, were randomized ... option for many skin and skin structure infections (SSSI) has become increasingly ... As part of the con- tinuing clinical development of ceftaroline, a phase 2 study was ..... Global epidemiology of antimicrobial resistance among.
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Integrated Analysis of CANVAS 1 and 2 - DukeSpace
Increasing antimicrobial resistance in cSSSI has led to a need for new safe and effective therapies. ... VAS 2. Complicated skin and skin-structure infections ( cSSSIs) ... Reprints or correspondence: Dr G. Ralph Corey, Gary Hock Professor of Global. Health ... Skin-Structure Infection), 2 phase 3 clinical trials that compared.
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Consensus document on controversial issues in the treatment of
Complicated skin and skin-structure infections (cSSSI), includ- ... Controlled Trials, and www.clinicaltrials.gov databases of randomized controlled trials and/ or ...
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Briefing Document for NI Margin Justification - U.S. Food and Drug
Nov 18, 2008 ... involving complicated skin and skin structure infections (cSSSI). .... In 1943 when penicillin became available for clinical study, the Com.
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AdCom Meeting BB - U.S. Food and Drug Administration
Sep 7, 2010 ... 20 ........................ 4.3.2 Complicated Skin and Skin Structure Infection ..... 63 .......... ............. 6.9.1 FDA-defined Clinical Response at Day 4 ..... Phase 3 Studies for cSSSI and CABP—Safety Population. 179 .......... Table ..... 4 large, global, randomized, placebo-controlled Phase 3 studies in 1240 subjects with.
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IDSA Comments on FDA's Draft Guidance for Industry on Acute
Nov 17, 2010 ... and Skin Structure Infections: Developing Drugs for Treatment; .... important single components of an overall, global understanding of ... higher clinical cure rate for cellulitis relative to sulfonamide therapy [7% ... In a modern dose- escalation study of complicated skin and skin structure infection (cSSSI),.
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Acute Bacterial Skin Infections: Developments Since the 2005
Patients with acute bacterial skin and skin structure infections (ABSSSI) commonly ... Although the global epidemiology of CA-MRSA is heterogenous, with multiple clones in .... Although tigecycline is indicated for ABSSSI, data from clinical trials suggest ... 4 mg/kg i.v. q24h over 0.5 h in 0.9% NaCl for 7–14 days in cSSSI.
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Efficacy and safety of tigecycline: a systematic review and meta
Jun 18, 2011 ... ... FDA for the treatment of complicated skin and skin structure infections (cSSSIs) , ... of 13 clinical trials.8 We conducted a meta-analysis of all RCTs .... cSSSI delafloxacin. 150. 14. 9.5 (5–14). 17.5 (14–21) not reported. McGovern ..... 29 Babinchak T, Zito E, Leister H. Global study of the efficacy of tigecycline ...
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An open-label, pragmatic, randomized controlled clinical trial to
Nov 3, 2015 ... complicated skin and skin structure infection. Teresa L. Kauf1*, Peggy McKinnon2, G. Ralph Corey3, John .... clinical trials of daptomycin for management of cSSSI ; .... a lot”) as measured by the Patient Global Impression of.
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CANVAS 2: the second Phase III, randomized, double-blind study
Objectives: New therapies for complicated skin and skin structure infections ( cSSSIs) are needed because of .... cSSSI site in patients who had clinical evidence of relapse. ...... global acceptability to regulators and investigators, the combi-.
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CANVAS 1: the first Phase III, randomized, double-blind study
Introduction. Complicated skin and skin structure infections (cSSSIs) are .... who met the minimal clinical criteria for a cSSSI and had received a speci- fied amount of ...... activity, safety and tolerability, and global acceptability to regu- lators and ...
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New insights into meticillin-resistant Staphylococcus aureus (MRSA
trials of agents used to treat serious MRSA infections, and accumulating data regarding the implications of antibacterial resistance in MRSA for clinical success during therapy. Recent ... complicated skin and skin-structure infections (cSSSI) and seri- ...... and susceptibility to antibiotics: a global analysis 2004–2009.
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Efficacy and safety of tigecycline monotherapy compared with - JMII
Two independent global Phase 3 trials, as well as a pooled ... The study design and methods for the two original clinical trials were .... cSSSI Z complicated skin and/or skin structure infection; c-mITT Z mITT subjects with evidence of cSSSI.
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Panton-Valentine Leukocidin Is Not the Primary Determinant - Plos
Staphylococcus aureus is the leading cause of complicated skin and skin structure infections (cSSSI) in the United States [1–4]. A number of studies have ... double-blind, multinational phase 3 clinical trials that compared the efficacy and ..... virulence and toxin expression of global community-associated methicillin- resistant ...
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1 Omadacycline (PTK 0796) Publications/Posters - Paratek
Noel. A Randomized, Evaluator-Blind, Phase 2 Study Comparing the Safety and · Efficacy of ... F-289. Flamm. Activity of Omadacycline Tested against Staphylococcus aureus from a Global .... Complicated Skin and Skin Structure Infections (cSSSI): Results of a PTK0796 · (PTK) Phase 2 Clinical Trial. Oct 25-28 ,. 2008.
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Efficacy, safety, tolerability and population pharmacokinetics of
Feb 7, 2016 ... Acute bacterial skin and skin structure infections are caused mainly by Gram- positive bacte- ria which are ... clinical trials (ESTABLISH-1 and ESTABLISH-2) conducted in patients with .... body mass index; cSSSI, complicated skin and skin structure infection; HIV ..... An ongoing global Phase 3 clinical study.
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Clinical Medicine Insights: Therapeutics emerging Treatment
While oritavancin doses in these studies varied, single daily doses of 200 mg ( 300 mg in patients ..... clinical studies. Complicated skin and skin structure infections. A phase II, randomized, ... quent Doses for the Treatment of cSSSI) of 302 cSS- ..... contemporary gram-positive pathogens submitted to a global surveillance.
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Jul 13, 2016 ... “cSSSI” complicated skin and skin structure infections;. “EMA” .... enrolling and dosing patients in two global Phase III clinical trials with an IV.
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