Archive for November 18, 2018

19/11/2018

* INFECTONEWS  2005 – 2018  ¡¡¡CUMPLE 13 AÑOS de VIDA!!! *

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Estamos llegando a los 9.500 artículos sobre infectología. Este blog siempre ha estado abierto gratuitamente a todo aquel que tenga deseos de actualizarse.

¡Muchas gracias a cada uno de Uds!

Atte

Dr. Jorge Omar Calabrese  – Tres Arroyos prov Bs Aires – Argentina

November 18, 2018 at 12:21 pm

FDA Approves Omadacycline for CABP and ABSSSI

This new-generation tetracycline carries less risk for bacterial drug resistance than older tetracyclines and fewer adverse effects than quinolones.

 

Omadiciclina – Prospecto del medicamento 24 pag

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf

 

Omadacycline Injection and Oral Products – FDA

FDA Identified Breakpoints

For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

For Community Acquired Bacterial Pneumonia (CABP)

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm622612.htm

 

FDA Clears Omadacycline (Nuzyra) for Two Infections – MEDSCAPE Oct 2018 1 pag

https://www.medscape.com/viewarticle/902885

 

Nuzyra Approval History

https://www.drugs.com/history/nuzyra.html

 

November 18, 2018 at 12:14 pm

Comparative In Vitro Activity of Omadacycline against Dog and Cat Bite Wound Isolates.

Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e02551-17.

Goldstein EJC1,2, Citron DM3, Tyrrell KL3, Leoncio E3, Merriam CV3.

Abstract

Omadacycline was tested against 125 isolates recovered from infected cat and dog bites in humans.

Its activity was similar to that of other compounds in the tetracycline class, and it was active against strains exhibiting tetracycline resistance.

Against anaerobic isolates, resistance to tetracyclines was more prominent and omadacycline was the most active of the group.

All isolates had omadacycline MICs of <1 μg/ml, with the exception of Eikenella corrodens, which showed reduced susceptibility to the entire tetracycline group.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5914009/pdf/e02551-17.pdf

November 18, 2018 at 11:58 am

In Vitro Activities of Omadacycline and Comparators against Anaerobic Bacteria.

Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e00047-18.

Stapert L1, Wolfe C1, Shinabarger D1, Marra A2, Pillar C1.

Abstract

Omadacycline (OMC), a broad-spectrum aminomethylcycline, has shown clinical efficacy in anaerobic acute bacterial skin and skin structure infections (ABSSSI) and in animal models of intra-abdominal anaerobic infections.

Here, the in vitro activity of OMC against clinically relevant anaerobes was similar to that of tigecycline, with MIC90 values of 1 to 8 μg/ml against Bacteroides spp., 0.5 μg/ml against Clostridium difficile, Prevotella spp., and Porphyromonas asaccharolytica, 1 μg/ml against Peptostreptococcus spp., and 16 μg/ml against Clostridium perfringens.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5913939/pdf/e00047-18.pdf

November 18, 2018 at 11:56 am

Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe as Part of the 2016 SENTRY Antimicrobial Surveillance Program.

Antimicrob Agents Chemother. 2018 Mar 27;62(4). pii: e02327-17.

Pfaller MA1,2, Huband MD3, Shortridge D1, Flamm RK1.

Abstract

Omadacycline was tested against 21,000 bacterial isolates collected prospectively from medical centers in Europe and the United States during 2016.

Omadacycline was active against Staphylococcus aureus (MIC50/MIC90, 0.12/0.25 mg/liter), including methicillin-resistant S. aureus (MRSA); streptococci (MIC50/MIC90, 0.06/0.12 mg/liter), including Streptococcus pneumoniae, viridans group streptococci, and beta-hemolytic streptococci; Enterobacteriaceae, including Escherichia coli (MIC50/MIC90, 0.5/2 mg/liter); Haemophilus influenzae (MIC50/MIC90, 1/1 mg/liter); and Moraxella catarrhalis (MIC50/MIC90, 0.25/0.25 mg/liter).

Omadacycline merits further study in serious infections where resistant pathogens may be encountered

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5913935/pdf/e02327-17.pdf

 

November 18, 2018 at 11:55 am

Safety and Pharmacokinetics of the Aminomethylcycline Antibiotic Omadacycline Administered to Healthy Subjects in Oral Multiple-Dose Regimens.

Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e01487-17.

Bundrant LA1, Tzanis E2, Garrity-Ryan L3, Bai S2, Chitra S2, Manley A2, Villano S2.

Abstract

Omadacycline, a first-in-class aminomethylcycline antibiotic, is related to tetracyclines but is structurally modified to circumvent mechanisms of resistance to tetracyclines.

Omadacycline demonstrates potent activity against a broad range of pathogens, including drug-resistant strains, and is in late-stage development for treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.

Previous studies support an intravenous-to-oral transition regimen with 300-mg once-daily oral dosing.

This phase 1 study investigated the pharmacokinetics and safety/tolerability of multiple oral omadacycline doses higher than 300 mg.

Using a 3-period crossover design, healthy adults were randomized to receive oral omadacycline at 300, 450, and 600 mg in variable sequence (n = 26) or placebo (n = 7) once daily for 5 consecutive days per period. In plasma, omadacycline maximum concentration and total exposure increased with increasing dose but were less than dose proportional.

The kinetics of omadacycline plasma accumulation were similar between dose levels; exposure on day 5 was ∼50% higher than that on day 1.

Omadacycline plasma concentrations on day 1 of 450-mg dosing were similar to those on day 5 of 300-mg dosing.

All doses were generally well tolerated, but the 600-mg dose was associated with more gastrointestinal adverse events.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5786815/pdf/e01487-17.pdf

November 18, 2018 at 11:54 am

Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function.

Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e02057-17.

Berg JK1, Tzanis E2, Garrity-Ryan L3, Bai S2, Chitra S2, Manley A2, Villano S2.

Abstract

Many antibiotics require dose adjustments in patients with renal impairment and/or in those undergoing hemodialysis.

Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad spectrum of bacterial pathogens, including drug-resistant strains.

Data from completed phase 3 studies of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) showed intravenous (i.v.) to once-daily oral omadacycline to be clinically effective and well tolerated.

To determine if the dosing of omadacycline should be adjusted in patients with impaired renal function, a phase 1 study examining the pharmacokinetics (PK) and safety of i.v. omadacycline (100 mg) was conducted in subjects with end-stage renal disease (ESRD) on stable hemodialysis (n = 8) and in matched healthy subjects (n = 8). i.v. administration of omadacycline produced similar plasma concentration-time profiles in subjects with ESRD and healthy subjects.

Further, in subjects with ESRD, similar values of the PK parameters were observed when omadacycline was administered i.v. after or before dialysis.

The mean area under the concentration-time curve from time zero extrapolated to infinity in plasma was 10.30 μg · h/ml when omadacycline was administered to ESRD subjects after dialysis, 10.20 μg · h/ml when omadacycline was administered to ESRD subjects before dialysis, and 9.76 μg · h/ml when omadacycline was administered to healthy subjects.

The mean maximum observed concentration of omadacycline in plasma in ESRD subjects was 1.88 μg/ml when it was administered after dialysis and 2.33 μg/ml when it was administered before dialysis, and in healthy subjects it was 1.92 μg/ml.

The 100-mg i.v. dose of omadacycline was generally safe and well tolerated in both ESRD and healthy subjects.

This study demonstrates that no dose adjustment is necessary for omadacycline in patients with impaired renal function or on days when patients are receiving hemodialysis.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5786750/pdf/e02057-17.pdf

November 18, 2018 at 11:52 am

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