Document Detail


A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections.
MedLine Citation:
PMID:  22908151     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A randomized, investigator-blind, multicenter phase 2 trial involving patients with complicated skin and skin structure infections (cSSSI) compared the safety and efficacy of omadacycline, a broad-spectrum agent with activity against methicillin-resistant Staphylococcus aureus (MRSA), to those of linezolid (with or without aztreonam). Patients were randomized 1:1 to omadacycline (100 mg intravenously [i.v.] once a day [QD] with an option to transition to 200 mg orally QD) or linezolid (600 mg i.v. twice daily [BID] with an option to transition to 600 mg orally BID) at 11 U.S. sites. Patients suspected or documented to have infections caused by Gram-negative bacteria were given aztreonam (2 g i.v. every 12 h [q12h]) if randomized to linezolid or matching placebo infusions if randomized to omadacycline. Adverse events were reported in 46 (41.4%) omadacycline-treated and 55 (50.9%) linezolid-treated patients. Adverse events related to treatment were assessed by investigators in 24 (21.6%) omadacycline-treated and 33 (30.6%) linezolid-treated patients. The gastrointestinal tract was most commonly involved, with adverse events reported in 21 (18.9%) patients exposed to omadacycline and 20 (18.5%) exposed to linezolid. Rates of successful clinical response in the intent-to-treat (ITT) and clinical evaluable (CE) populations favored omadacycline (ITT, 88.3% versus 75.9%; 95% confidence interval [CI], 1.9 to 22.9; CE, 98.0% versus 93.2%; 95% CI, -1.7 to 11.3). For microbiologically evaluable (ME) patients with S. aureus infections, the clinical success rates were 97.2% (70/72) in omadacycline-treated and 92.7% (51/55) in linezolid-treated patients. This phase 2 experience supports conclusions that omadacycline is well tolerated in cSSSI patients and that this aminomethylcycline has potential to be an effective treatment for serious skin infections.
Authors:
Gary J Noel; Michael P Draper; Howard Hait; S Ken Tanaka; Robert D Arbeit
Publication Detail:
Type:  Clinical Trial, Phase II; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-08-20
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  56     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-10-17     Completed Date:  2013-04-23     Revised Date:  2013-07-12    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  5650-4     Citation Subset:  IM    
Affiliation:
Paratek Pharmaceuticals Inc., Boston, Massachusetts, USA. gjnoel14@gmail.com
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MeSH Terms
Descriptor/Qualifier:
Acetamides / administration & dosage*,  adverse effects
Adolescent
Adult
Aged
Anti-Bacterial Agents / administration & dosage*,  adverse effects
Aztreonam / administration & dosage*,  adverse effects
Drug Administration Schedule
Female
Humans
Injections, Intravenous
Male
Methicillin-Resistant Staphylococcus aureus / drug effects*,  growth & development
Middle Aged
Minocycline / administration & dosage*,  adverse effects,  analogs & derivatives
Oxazolidinones / administration & dosage*,  adverse effects
Placebos
Skin / drug effects*,  microbiology
Skin Diseases, Bacterial / drug therapy*,  microbiology
Staphylococcal Infections / drug therapy*,  microbiology
Treatment Outcome
Chemical
Reg. No./Substance:
0/Acetamides; 0/Anti-Bacterial Agents; 0/Oxazolidinones; 0/Placebos; 10118-90-8/Minocycline; 165800-03-3/linezolid; 78110-38-0/Aztreonam
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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