GC Therapy –  Shooting for the Stars

Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead Continue reading GC Therapy –  Shooting for the Stars

Efficacy and Treatment Duration: Where is the Tipping Point?

Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?

Google Search for News on “Antibiotics”

The top-line news articles that come up on a Google search when one enters the term “antibiotics” is truly an eclectic bunch. Here is Page 1 of search results after eliminating some duplications. We have a few comments on these Continue reading Google Search for News on “Antibiotics”

The Monoclonal Pursuit of the Next CMV Therapeutic

There is no doubt that immunity to human cytomegalovirus (CMV) is both cell-and antibody-mediated. Studies in transplant patients showed that absence of T-cell protection with chemotherapy is a set-up for recurrent and severe CMV disease. It was also shown that patients Continue reading The Monoclonal Pursuit of the Next CMV Therapeutic

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

CDC Report on Pan-Resistant NDM Klebsiella in Nevada– A Sad Tale

During the past few weeks the case of a patient with MDR Klebsiella infection has made the news. We are told that this particular pathogen is “resistant to 26 antibiotics”. We were informed that the patient had multiple prior hospitalizations Continue reading CDC Report on Pan-Resistant NDM Klebsiella in Nevada– A Sad Tale

Is the AOM Indication Making a Come-Back?

We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue Continue reading Is the AOM Indication Making a Come-Back?

Aradigm Lost in ORBIT – Hayward, We Have a Problem

It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem

Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts

INSMED – NTM The company that is developing Arikayce, a preparation of liposomal amikacin inhalation (LAI), for the treatment of NTM had to withdraw its MAA in Europe earlier this year [1] because data was not convincing enough for regulators to Continue reading Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts

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

Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Often we come across a study which raises more questions than it answers.  Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Profiling Solithromycin: FDA AMDAC on Solithera

Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for Continue reading Profiling Solithromycin: FDA AMDAC on Solithera

Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

QIDP Drug Update – Part 2:  Categories of Interest

According to Janet Woodcock, 63 drugs have been given the “QIDP” designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.  So we are in fairly close agreement. That Continue reading QIDP Drug Update – Part 2:  Categories of Interest

Sulfonamides Revisited, With an Emphasis on Dapsone

The sulfonamide moiety is a remarkable structure giving rise to diverse drugs in arious therapeutic areas such as antibiotics, antidiabetics, diuretics and anti-inflammatory agents. In regards to antibiotics, sulfonamides are in common use as antifungals (P. jiroveci), antiparasitics (toxoplasmosis, cyclospora, isospora, Continue reading Sulfonamides Revisited, With an Emphasis on Dapsone