Ceftaroline Approved

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I would be interested in the gram negative spectrum. Right now we have approval for CAP, as it was compared to CTX in clinical trial. Does it have anti-pseudomonal activity, but not tested in trials? Obviously you worry about resistance with these super antbiotics, in if we are using it for just MRSA, are we inducing resistance to G-.... I think of tigecycline which was supposed to be the be all, end all antibiotic and did not live up to the hype.

5th generation...wow, I feel old.
 
I'm sure there are colonies of MRSA shaking in their boots. Meanwhile in a community hospital in Oklahoma 5GCephRSA bactermia has already claimed 4 victims... We'll come to find in the months to come a new mechanism of resistance: PagnomBP-1

"Penicillin Aint Got Nothin On Me Binding Protein-1"
 
KARM12 said:
I would be interested in the gram negative spectrum. Right now we have approval for CAP, as it was compared to CTX in clinical trial. Does it have anti-pseudomonal activity, but not tested in trials? Obviously you worry about resistance with these super antbiotics, in if we are using it for just MRSA, are we inducing resistance to G-.... I think of tigecycline which was supposed to be the be all, end all antibiotic and did not live up to the hype.

5th generation...wow, I feel old.
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There was an article published in AAC last year with in vitro tests against a bunch of gram-negatives. It had decent activity against non-ESBL Enterobacteriaceae, but imipenem was better on all counts. Very low-level activity against Pseud, so its probably not worth it. They didn't test against cefepime, just levofloxaxin, ceftriaxone and imipinem. I'll see if I have it lying around and post the citation.

Going off of the two trials that got it approved, I really don't think this is going to see that much widespread use.
 
Praziquantel86 said:
There was an article published in AAC last year with in vitro tests against a bunch of gram-negatives. It had decent activity against non-ESBL Enterobacteriaceae, but imipenem was better on all counts. Very low-level activity against Pseud, so its probably not worth it. They didn't test against cefepime, just levofloxaxin, ceftriaxone and imipinem. I'll see if I have it lying around and post the citation.

Going off of the two trials that got it approved, I really don't think this is going to see that much widespread use.
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Thanks!

So far the only advantage is 1 versus 2 drugs? CTX plus vanc is much cheaper.
 
WVUPharm2007 said:
Or you could just read my post and trust my word that we shouldn't care about it.
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Hush...not many new antibiotics come to market so we get really excited when they do. Granted, this one isn't that great, but let us ID people have our moment.

🙂
 
Here you go:

Brown SD, Traczewski MM. In Vitro Antimicrobial Activity of a New Cephalosporin, Ceftaroline, and Determination of Quality Control Ranges for MIC Testing. AAC. 2009, 53(3)1271-4.

The spectrum of activity of ceftaroline was evaluated against 1,271 bacterial isolates representing 44 different species or phenotypic groups. For the majority of species, the activity of ceftaroline was comparable or superior to that of ceftriaxone. MIC and/or disk diffusion quality control ranges of ceftaroline were determined for five standard ATCC reference strains.

I definitely don't buy this being used for anything gram-negative.
 
I just look at it as a stepped on, ghetto version of ceftobiprole...of course I'm not a fancy ID specialist and I haven't stepped foot in a pharmacy in almost a year, so WTF do I know...
 
WVUPharm2007 said:
I just look at it as a stepped on, ghetto version of ceftobiprole...of course I'm not a fancy ID specialist and I haven't stepped foot in a pharmacy in almost a year, so WTF do I know...
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Ceftobiprole never made it to market. The FDA asked J&J to do more clinical trials after they questioned the validity of a few of the trials. I think they gave up on it because I haven't heard anything recently.
 
KARM12 said:
Ceftobiprole never made it to market. The FDA asked J&J to do more clinical trials after they questioned the validity of a few of the trials. I think they gave up on it because I haven't heard anything recently.
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Yeah, I know.

And that doesn't change the fact that this new drug is a stepped on version of it.

...

Actually, I'ma need y'all to give me an update on the last year of **** that happened. I'm sure something important happened since last January or so. Fill me in.

They figure out something better than anal massages and Thorazine for hiccups yet?
 
WVUPharm2007 said:
They figure out something better than anal massages and Thorazine for hiccups yet?
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I used to hold my breath for 10 seconds, but I am definitely trying this next time! Now I just have to wait for the next hiccup attack...
 
Financially speaking, treatment of MRSA/VRE is what I'm interested in.

Zyvox is around $200 per day IV. Tygacil is useless for MRSA Pneumonia... Dapto is useless for MRSA pneumonia...

So if this cepha can come in below $100 per day, then I may suggest this over Zyvox in places where Vanco is not feasible.
 
KARM12 said:
Ceftobiprole never made it to market. The FDA asked J&J to do more clinical trials after they questioned the validity of a few of the trials. I think they gave up on it because I haven't heard anything recently.
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It was approved in Canada in 2008, and voluntarily discontinued by Janssen Ortho in April 2010 because of the conduct of the clinical trials.

My friends in hosp say it wasn't used much - the ID people didn't think there was enough evidence.
 
Its Z said:
Financially speaking, treatment of MRSA/VRE is what I'm interested in.

Zyvox is around $200 per day IV. Tygacil is useless for MRSA Pneumonia... Dapto is useless for MRSA pneumonia...

So if this cepha can come in below $100 per day, then I may suggest this over Zyvox in places where Vanco is not feasible.
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The VRE activity of ceftaroline looks pretty spotty. It has activity against VS-E. faecium, but really is no better that ceftriaxone against E. faecium. It does have activity against both VS- and VR- E. faecalis, though. A lot of institutions don't speciate out the enterococcal strains, so this may theoretically give them a reason to begin doing so.

I'll agree that if the pricing is right, this could be a good option for pneumonia. Especially those cases where you're borderline unsure of whether it's CAP/HAP, it may be a decent option.

What are your thoughts on the optimal dosing for this? I haven't seen any of the PK studies, so I don't know what sort of levels it was achieving with the 600mg q12 dosing. Could be a nice time for a Monte Carlo simulation...
 
Nov 4 issue of pharmacotherapy has a review article. I have it but didn't read it line by line...I just read the abstract and the summary.

Seems to be well written.
 
Its Z said:
Financially speaking, treatment of MRSA/VRE is what I'm interested in.

Zyvox is around $200 per day IV. Tygacil is useless for MRSA Pneumonia... Dapto is useless for MRSA pneumonia...

So if this cepha can come in below $100 per day, then I may suggest this over Zyvox in places where Vanco is not feasible.
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Well certainly in the oncology setting when we worry about thrombocytopenia associated with linezolid use (even though rare), its still gives us another option.
 
Quiksilver said:
Well certainly in the oncology setting when we worry about thrombocytopenia associated with linezolid use (even though rare), its still gives us another option.
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Daptomycin...

Is a being a cancer patient a contraindication for linezolid therapy? When do we usually see thrombocyopenia develop?
 
KARM12 said:
Daptomycin...

Is a being a cancer patient a contraindication for linezolid therapy? When do we usually see thrombocyopenia develop?
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It isn't a contraindication per se, but in liquid tumors the idea behind therapy is to be myelosuppressive which means in a lot of patients will have thrombocytopenia as a result. So if they have an active infection they will surely be on antibiotics for at least a few weeks, especially if they are experiencing febrile neutropenia. The risk of thrombocytopenia increases as the duration of therapy increases. So the question becomes why take the risk if there are other options.

Daptomycin works, except for those cases that are pneumonia. A lot of them are pneumonia, but a lot of them are sensitive to vanco anyways. In bone marrow transplant, this probably would see more action because patients are kept more in house and infections are the nocosomial sort.
 
dang it..a group of 8 middle aged vacationing women took up the entire first class...preventing an upgrade on a long flite to an exotic island! people shouldnt be vacationing in november!😡
 
Quiksilver said:
It isn't a contraindication per se, but in liquid tumors the idea behind therapy is to be myelosuppressive which means in a lot of patients will have thrombocytopenia as a result. So if they have an active infection they will surely be on antibiotics for at least a few weeks, especially if they are experiencing febrile neutropenia. The risk of thrombocytopenia increases as the duration of therapy increases. So the question becomes why take the risk if there are other options.

Daptomycin works, except for those cases that are pneumonia. A lot of them are pneumonia, but a lot of them are sensitive to vanco anyways. In bone marrow transplant, this probably would see more action because patients are kept more in house and infections are the nocosomial sort.
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Good, now you're thinking.

My next question for the group....

Enterococcus is commonly isolated in 2 species. VRE is more commonly associated with 1 strain of enterococcus (~80%). What is the strain and what about this strain may make the use of this new drug questionable? Does this then bring us back to the dapto vs. linezolid question?
 
KARM12 said:
Good, now you're thinking.

My next question for the group....

Enterococcus is commonly isolated in 2 species. VRE is more commonly associated with 1 strain of enterococcus (~80%). What is the strain and what about this strain may make the use of this new drug questionable? Does this then bring us back to the dapto vs. linezolid question?
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too easy..
 
KARM12 said:
Good, now you're thinking.

My next question for the group....

Enterococcus is commonly isolated in 2 species. VRE is more commonly associated with 1 strain of enterococcus (~80%). What is the strain and what about this strain may make the use of this new drug questionable? Does this then bring us back to the dapto vs. linezolid question?
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E. faecium - They have intrinsic resistance to most Beta Lactam drugs b/c their PBP have lower affinity for the drugs.
 
gosh dayum, i failed to jack my own thread.
 
Its Z said:
dang it..a group of 8 middle aged vacationing women took up the entire first class...preventing an upgrade on a long flite to an exotic island! people shouldnt be vacationing in november!😡
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thats because many peeps here are still haunted by the 300K debt- thread to see the significance of your predicament.

quite frankly, I thought it was exhibitionist at best. Anyways, enjoy your exotic venture.
 
TemSirolimus said:
thats because many peeps here are still haunted by the 300K debt- thread to see the significance of your predicament.

quite frankly, I thought it was exhibitionist at best. Anyways, enjoy your exotic venture.
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I'm not vacationing. I'm working. What maybe be an exotic vacation destination to many is really a 3rd world country behind a facade. There's really nothing glamourous about doing consulting work at a poor indigent 3rd world country hospital.
 
Its Z said:
Nov 4 issue of pharmacotherapy has a review article. I have it but didn't read it line by line...I just read the abstract and the summary.

Seems to be well written.
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You mean issue 4 (April 2010)?? By the Vancomycin King?
 
WVUPharm2007 said:
I just look at it as a stepped on, ghetto version of ceftobiprole...of course I'm not a fancy ID specialist and I haven't stepped foot in a pharmacy in almost a year, so WTF do I know...
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I am with you on this one.....however, a beta lactam active against ORSA is impressive to me.
 
WVUPharm2007 said:
You're alive!
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Can you think of a reason for me to have been hiding under a rock lately?? I mean, let us be clear, it wasn't due to the TIM TEBOW TOUCHDOWN Sunday......I know you were cheering.
 
WVUPharm2007 said:
They let him play...like...in a game? Amazing.
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I believe his stats for the season are as follows:

2 carries, 2 yards, 2 touchdowns. So they let him in 2 real games.

I am pretty sure they will invite him to New York this year as a Heisman finalist.
 
I didn't know I was being quizzed. I thought you were asking me for my personal opinion in the matter. All the same, we still try to avoid linezolid when we can.
 
Quiksilver said:
I didn't know I was being quizzed. I thought you were asking me for my personal opinion in the matter. All the same, we still try to avoid linezolid when we can.
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No just discussing what you think is the best therapy. So if not linezolid, then?
 
Priapism321 said:
You mean issue 4 (April 2010)?? By the Vancomycin King?
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NO YOU FOO!

Ceftaroline: A New Cephalosporin with Activity Against
Resistant Gram-Positive Pathogens​
Molly E. Steed, Pharm.D., and Michael J. Rybak, Pharm.D., M.P.H.

PHARMACOTHERAPY Volume 30, Number 4, 2010

Ceftaroline is a novel, broad-spectrum, advanced-generation cephalosporin
whose action is mediated by binding to penicillin-binding proteins in bacteria,
consistent with other -lactam antibiotics. Ceftaroline is distinct in that it has
antimicrobial activity against multidrug-resistant​
​
​
​
Staphylococcus aureus​

(including methicillin-resistant​
​
​
​
S. aureus, vancomycin-intermediate S. aureus​

[VISA], heteroresistant VISA, and vancomycin-resistant​
​
​
​
S. aureus),​

Streptococcus pneumonia​
​
​
​
​
(including drug-resistant strains), and respiratory
gram-negative pathogens such as Moraxella catarrhalis and Haemophilus
influenzae (including -lactamase–positive strains). Development of
resistance to ceftaroline occurs rarely in gram-positive bacteria and at a
similar rate to that of other oxyimino-cephalosporins in gram-negative
bacteria. The inactive prodrug, ceftaroline fosamil, is administered by
intravenous infusion and rapidly undergoes biotransformation to ceftaroline.
Ceftaroline then follows a two-compartment pharmacokinetic model and is
eliminated primarily by renal excretion, with a half-life of approximately 3
hours. Similar to other cephalosporins, time above the minimum inhibitory
concentration is the pharmacodynamic parameter that best predicts efficacy
for ceftaroline. Ceftaroline 600 mg intravenously every 12 hours has been
shown to have similar efficacy to vancomycin plus aztreonam for the
treatment of complicated skin and skin structure infections and to ceftriaxone
for the treatment of community-acquired bacterial pneumonia in phase III
clinical trials. Ceftaroline displayed a safety profile similar to that of other
cephalosporins in clinical trials. Dosage adjustment is required for moderate
renal impairment and for patients receiving hemodialysis. Ceftaroline
breakpoints have been proposed but not confirmed. Ceftaroline is a renally
excreted broad-spectrum cephalosporin that is clinically effective for the
treatment of complicated skin and skin structure infections and communityacquired
bacterial pneumonia, and it has distinctive activity against some
difficult-to-treat multidrug-resistant gram-positive organisms.​

Key Words:​
​
​
​
​
ceftaroline, TAK-599, PPI-0903, PPI-0903M, T-91825, methicillinresistant​

Staphylococcus aureus​
​
​
​
​
, MRSA, cephalosporin.​

(Pharmacotherapy 2010;30(4):375–389)
 
btw,

If y'all want the article, send me a PM with your email addy..b-day, SS#...full name..and address.

Maybe I'll get dressed and go to work now 👎 instead of drinking coffee looking out a beautiful tropical cove..
 
Its Z said:
btw,

If y'all want the article, send me a PM with your email addy..b-day, SS#...full name..and address.

Maybe I'll get dressed and go to work now 👎 instead of drinking coffee looking out a beautiful tropical cove..
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You got a cost for this fancy new crap? I bet it costs an arm and a significant portion of a budget. Also, any weird administration/physical product delivery issues?
 
I suck at ID, I wish I were better. anyone have an online guide that isn't the CDC website?
 
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