All Smiles at the Press Conference: Plazo+Levo Delivers

This December, Achaogen released much data on 2 plazomicin trials[1]: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers

To Kill A Mocking Bug – of the CRKP or CRAB Variety

Meropenem stands out as an antibiotic to be used first in ESBL and MDR infections, given its efficacy profile and safety record (see earlier blog). It also would seem to be appropriate to use relatively high doses or prolonged infusion Continue reading To Kill A Mocking Bug – of the CRKP or CRAB Variety

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

VABP is clearly the main indication to be pursued by a drug like POL7080.  Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum?  Which is actually no spectrum at all.  Existing Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

Avycaz Approval and Labeling Restrictions

On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is Continue reading Avycaz Approval and Labeling Restrictions