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
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Posted in Recent Literature, The News, The Viewpoint |
Tagged afelimomab, Allphase Pharma Consulting, anti-IL-1, anti-PAF, anti-TNF mAb, antibiotic blog, Bayer, Bone criteria, Centocor, Chiron, drotrecogin, E5, Eisai, endotoxin, HA-1A, Harald Reinhart, ICU mortality, Ipsen, MAP 195, Novartis, Roche, sepsis, sepsis syndrome, septic shock, severe sepsis, SIRS, SIRS criteria, steroids, Synergen, TFPI, Tifacogin, Xigris, Xoma |
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
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Posted in The News, The Viewpoint |
Tagged ABECB, ABECB-COPD, ABS, adverse events, AIDAC, Allphase Pharma Consulting, AMDAC, antibiotic blog, Avelox, Bayer, bronchitis, Cipro, ciprofloxacin, COPD, Factive, FDA, fluoroquinolone, fosfomycin, gemifloxacin, Harald Reinhart, Johnson & Johnson, Levaquin, levofloxacin, mastoiditis, moxifloxacin, nitrofurantoin, ofloxacin, otitis media, peripheral neuropathy, pneumonia, QTc, sepsis, sinusitis, tendonitis, urinary tract infection, uUTI |
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”
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Posted in QIDP Antibiotics, The News, The Viewpoint |
Tagged antibiotic blog, bacteremia, bronchiectasis, Cubicin, Cubist, daptomycin, Doribax, doripenem, endocarditis, FDA, Francis Tally, malignant otitis externa, MRSA, P. aeruginosa, POL7080, Polyphor, RG-7929, Roche, sepsis, tigecycline, Tygacil, UTI, VABP, VAP, VAP bundle |
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
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Posted in Did you know...?, The News, The Viewpoint |
Tagged ABECB, ABECS, ABSSSI, AECB, Allphase Pharma Consulting, anti-infective indications, antibiotic blog, Avycaz, bacteremia, bacterial bronchitis, bacterial otitis media, bacterial sinusitis, ceftaroline, Ceftazidime/avibactam, ceftolozane/tazobactam, cIAI, Cubicin, Cubist, cUTI, daptomycin, drotrecogin, endocarditis, FDA, Francis Tally, HABP, Levaquin, levofloxacin, MDR pathogen trials, meningitis, MRSA, nosocomial pneumonia, osteomyelitis, prosthetic joint infection, S. aureus, sepsis, Sivextro, tedizolid, Teflaro, TFPI, thrombomodulin, Tifacogin, VABP, Xigris, Zerbaxa |
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
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Posted in Recent Literature, The Viewpoint |
Tagged antibiotic blog, bacteremia, bacterial dialysis, bacterial trapping, Bayer, dialysis, drotrecogin, E5 mAb, Eisai, endotoxin, Eritoran, HA1A, Lilly, liposomes, LPS, mannose-binding protein, MBP, MSOF, multi-system organ failure, nanoparticles, Roger Bone, sepsis, sepsis syndrome, septic shock, steroids, TFPI, Tifacogin, TNF-alpha inhibitor, toxemia, toxin binding, Xigris |