Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance

2019 ◽  
Vol 14 (15) ◽  
pp. 1293-1308
Author(s):  
Joseph S Solomkin ◽  
Angie Sway ◽  
Kenneth Lawrence ◽  
Melanie Olesky ◽  
Sergey Izmailyan ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Phase Iii ◽  
Two Phase ◽  
Carbapenem Resistant ◽  
Phase Iii Trials ◽  
New Treatment ◽  
Intent To Treat ◽  
Intra Abdominal Infection ◽  
Abdominal Infections ◽  
Cure Rates

Aim: Recently approved for use in complicated intra-abdominal infection, eravacycline is a novel fluorocycline with broad spectrum of activity against resistant Gram-negative pathogens. This manuscript is a pooled analysis of two Phase III trials. Clinical efficacy: Clinical cure rates were 86.8% for eravacycline versus 87.6% for ertapenem, and 90.8% for eravacycline versus 91.2% for meropenem in the Intent to Treat (micro-ITT) populations, and 87.0% for eravacycline versus 88.8% ertapenem, and 92.4 versus 91.6% for meropenem in the Modified Intent to Treat (MITT) populations. Safety: Eravacycline is well tolerated, with lower rates of nausea, vomiting and diarrhea than other tetracyclines. Conclusion: Eravacycline is an effective new option for use in complicated intra-abdominal infections, and in particular, for the treatment of extended-spectrum β-lactamase- and carbapenem-resistant Enterobacteriaceae-expressing organisms.

Incobotulinumtoxina (Xeomin) sustainably improves upper limb spasticity: Pooled analysis of two phase III trials

Toxicon ◽  
2016 ◽  
Vol 123 ◽  
pp. S47
Author(s):  
Petr Kaňovský ◽  
Elie P. Elovic ◽  
Michael C. Munin ◽  
Angelika Hanschmann ◽  
Irena Pulte ◽  
...  
Keyword(s):  
Upper Limb ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Two Phase ◽  
Phase Iii Trials ◽  
Limb Spasticity

scholarly journals Comparative Susceptibilities to Fidaxomicin (OPT-80) of Isolates Collected at Baseline, Recurrence, and Failure from Patients in Two Phase III Trials of Fidaxomicin against Clostridium difficile Infection

2011 ◽  
Vol 55 (11) ◽  
pp. 5194-5199 ◽  
Author(s):  
Ellie J. C. Goldstein ◽  
Diane M. Citron ◽  
Pamela Sears ◽  
Farah Babakhani ◽  
Susan P. Sambol ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Restriction Endonuclease Analysis ◽  
Phase Iii ◽  
Two Phase ◽  
Double Blind ◽  
Single Strain ◽  
Content Type ◽  
Treatment Groups ◽  
Phase Iii Trials ◽  
Intent To Treat

ABSTRACTA 10-day course of oral fidaxomicin (200 mg twice a day [b.i.d.]), a potent new macrocyclic drug, was compared to vancomycin (125 mg four times a day [q.i.d.]) in 1,164 adults (1,105 in the modified intent-to-treat [mITT] population) withClostridium difficileinfection in two phase III randomized, double-blind trials at sites in North America and 7 European countries. Of 1,105 mITT patients, 792 (71.7%), including 719/999 (72.0%) in the per-protocol (PP) population, provided aC. difficilestrain at baseline, of whom 356 received fidaxomicin with 330 cures (92.7%) and 363 received vancomycin with 329 cures (90.6%). The susceptibilities (MIC90) of baseline isolates did not predict clinical cure, failure, or recurrence for fidaxomicin (MIC90, 0.25 μg/ml for both; range, ≤0.007 to 1 μg/ml), but there was a one-dilution difference in the MIC90(but not the MIC50) for vancomycin (MIC90, 2 μg/ml [range, 0.25 to 8 μg/ml] for cure and 4.0 μg/ml [range, 0.5 to 4 μg/ml] for failures). A total of 65 (7.9%) “rifaximin-resistant” (MIC > 256 μg/ml) strains were isolated in both treatment groups on enrollment, which increased to 25% for failures at the end of therapy. No resistance to either fidaxomicin or vancomycin developed during treatment in either of the phase III studies, although a single strain isolated from a cured patient had an elevated fidaxomicin MIC of 16 μg/ml at the time of recurrence. All isolates were susceptible to ≤4 μg/ml of metronidazole. When analyzed by restriction endonuclease analysis (REA) type, 247/719 (34.4%) isolates were BI group isolates, and the MICs were generally higher for all four drugs tested (MIC90s: fidaxomicin, 0.5; vancomycin, 2.0; metronidazole, 2.0; and rifaximin, >256 μg/ml) than for the other REA types. There was no correlation between the MIC of a baseline clinical isolate and clinical outcome. MIC90s were generally low for fidaxomicin and vancomycin, but BI isolates had higher MICs than other REA group isolates.

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