Allphase Pharma Consulting, LLC
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SIRS, sepsis, severe sepsis, septic shock is a continuum, a crescendo of signs and symptoms associated with an infection uncontrolled by host responses. An avalanche or cascade of seemingly unstoppable events occurs often in a matter of hours which has Continue reading Recent Sepsis Literature
Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public. The topic of the December 5th meeting: Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI – Part 1
Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 2)
It is no secret that most existing antibiotic guidelines are not getting much use these days. The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP. Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)
There is hardly an indication which has accumulated more failed clinical trials than the sepsis area. Called first bacteremia, later sepsis, sepsis syndrome or septic shock, there have been numerous attempts to influence the cascade of events that eventually lead Continue reading Two New Approaches For Dealing with Sepsis / Toxemia