In a general obstetrical population, prenatal testing with the use of cfDNA had significantly lower false positive rates and higher positive predictive values for detection of trisomies 21 and 18 than standard screening. (Funded by Illumina; ClinicalTrials.gov number, NCT01663350.).
Once-weekly intravenous dalbavancin was not inferior to twice-daily intravenous vancomycin followed by oral linezolid for the treatment of acute bacterial skin and skin-structure infection. (Funded by Durata Therapeutics; DISCOVER 1 and DISCOVER 2 ClinicalTrials.gov numbers, NCT01339091 and NCT01431339.).
NTIMICROBIALS AVAILABLE FOR treatment of complicated skin and skin structure infections (SSSIs) are generally efficacious, but antimicrobial resistance 1-7 and adverse effects limit their use. 1,8,9 Linezolid, an oxazolidinone, is the only drug approved for complicated SSSI caused by methicillinresistant Staphylococcus aureus (MRSA). Sporadic outbreaks of linezolidresistant strains of MRSA and enterococci, including those carrying a plasmid-borne cfr gene encoding the chloramphenicol/florfenicol resistance protein, have been reported. 10 Significant safety concerns with linezolid have emerged since it was approved in 2000 by the US Food and Drug Administration (FDA). 11 In 2010, the FDA issued a draft guidance for the development of systemic drugs to treat acute bacterial SSSIs (ABSSSIs) with recommendations for clinical response criteria and noninferiority trial design. 12,13 Given the time required to develop and obtain approval for a new chemical entity, trials demonstrating noninferiority to currently approved antimicrobials allow the development of new agents in advance of the selection of resistant pathogens in hospitals or in the community. Even within the same class of For editorial comment see p 609.
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