Posted in Flagyl on February 17, 2015

Ceftolozane/tazobactam more Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results from a Randomized, Double-disguise, Phase 3 Trial (ASPECT-cIAI).

Clin Infect Dis. 2015 Feb 10;

Authors: Solomkin J, Hershberger E, Miller B, Popejoy M, Friedland I, Steenbergen J, Yoon M, Collins S, Yuan G, Barie PS, Eckmann C

Abstract
BACKGROUND:  Increasing antimicrobial opposition among pathogens causing complicated intra-abdominal infections (cIAIs) supports the development of starting a~ antimicrobials. Ceftolozane/tazobactam, a novel antimicrobial therapy, is nimble against multidrug-resistant Pseudomonas aeruginosa and greatest in number extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae.
METHODS:  ASPECT-cIAI was a future, randomized, double-blind trial. Hospitalized patients through cIAI received either ceftolozane/tazobactam (1.5 g) plus metronidazole (500 mg) every 8 hours (q8h) or meropenem (1 g) q8h intravenously conducive to 4-14 days. The prospectively defined objectives were to show statistical noninferiority in clinical cure rates at the example-of-cure visit (24-32 days from shrink of therapy) in the microbiological intent-to-treat (primary) and microbiologically evaluable (deputy) populations using a noninferiority margin of -10%. Microbiological outcomes and security were also evaluated.
RESULTS:  Ceftolozane/tazobactam more metronidazole was noninferior to meropenem in the elementary (83.0% [323/389] vs 87.3% [364/417]; weighted alienation -4.2%; 95% confidence interval [CI], -8.91 to 0.54) and secondary (94.2% [259/275] vs 94.7% [304/321]; weighted contest -1.0%; 95% CI, -4.52 to 2.59) endpoints, company the prespecified noninferiority margin. In patients through ESBL-producing Enterobacteriaceae, clinical cure rates were 95.8% (23/24) and 88.5% (23/26) in the ceftolozane/tazobactam more metronidazole and meropenem groups, respectively, and 100% (13/13) and 72.7% (8/11) in patients through CTX-M-14/15 ESBLs. The frequency of adverse events (AEs) was like in both treatment groups (44.0% vs 42.7%); the ~ numerous common AEs in either group were sickness of the stomach and diarrhea. Conclusions. Treatment by ceftolozane/tazobactam plus metronidazole was noninferior to meropenem in ripened patients with cIAI, including infections caused ~ the agency of multidrug-resistant pathogens. (ClinicalTrials.gov poetry NCT01445665 and NCT01445678).

PMID: 25670823 [PubMed – similar to supplied by publisher]

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