AWARE®: Assessing Worldwide Antimicrobial Resistance Evaluation: U.S. Data

Surveillance of Antibiotic Activity Tested Against Clinical Isolates in the United States4

2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014

Stay informed with AWARE data for ceftaroline regional susceptibility. Bacterial resistance continues to evolve and varies by geographical location. We know, because we've been keeping our eye on it. To keep you informed, we're offering data from the AWARE surveillance program. It's an easy was to see the susceptibility rates of ceftaroline in your region — anywhere in the country.

Read Full Study Design Below

Interactive Regional Susceptibilities Table, 20141

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO was statistically superior to vancomycin plus aztreonam or to ceftriaxone.

Select a pathogen and region to show susceptibility for that region.


Select Pathogen

Select Region

TEFLARO is indicated for ABSSSI due to MRSA. It is not indicated for CABP due to MRSA.


S. pneumoniae Respiratory Isolates: 99.9% Susceptible to Ceftaroline (2008-2014)

National Susceptibilities, 2008-20144

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO® (ceftaroline fosamil) was statistically superior to ceftriaxone.


MSSA Respiratory and Skin Isolates: 100% Susceptible to Ceftaroline (2008-2014)

National Susceptibilities, 2008-20144

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO was statistically superior to ceftriaxone or vancomycin plus aztreonam.


MRSA Skin Isolates: >97% Susceptible to Ceftaroline (2008-2014)

National Susceptibilities, 2008-20144

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO was statistically superior to vancomycin plus aztreonam.

Back to Top


S. pneumoniae MIC Distribution 2014: % of isolates at MIC4

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO® (ceftaroline fosamil) was statistically superior to ceftriaxone.

MIC
(µg/mL)
Ceftaroline
(N=1652) MIC90=0.12
Ceftriaxone
(N=1652) MIC90=1
≤0.015 59.3
0.03 11.1
0.06 11 57.7
0.12 14.7 11.1
0.25 3.5 6.3
0.5 0.4* 7
1 0.1 12.3*
2 4.8
4 0.5
4 0.5
8 0.4
Total % Susceptible 99.9% 94.3%
MIC
(µg/mL)
Ceftaroline
(N=1652) MIC90=0.12
Ceftriaxone
(N=1652) MIC90=1
≤0.015 59.3
0.03 11.1
0.06 11 57.7
0.12 14.7 11.1
0.25 3.5 6.3
0.5 0.4* 7
1 0.1 12.3*
2 4.8
4 0.5
4 0.5
8 0.4
Total % Susceptible 99.9% 94.3%

FDA susceptible breakpoint.


MSSA MIC Distribution 2014:
% of isolates at MIC4

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO was statistically superior to vancomycin plus aztreonam or to ceftriaxone.

MIC
(µg/mL)
Ceftaroline
(n=2995) MIC90=0.25
Ceftriaxone
(N=2995) MIC90=4
Vancomycin
(N=2995) MIC90=1
0.015 0
0.03 0.1
0.06 0.4
0.12 7.7 0.03
0.25 86.5 0 0.1
0.5 5.2 0.07 23.0
1 0.03* 0.6 76.4
2 4.6 0.5*
4 84.1*
8 10.2
>8 0.3
Total %
Susceptible
100% 89.5% 100%
MIC
(µg/mL)
Ceftaroline
(N=2995)
MIC90=0.25
Ceftriaxone
(N=2995)
MIC90=4
Vancomycin
(N=2995)
MIC90=1
0.015 0
0.03 0.1
0.06 0.4
0.12 7.7 0.03
0.25 86.5 0 0.1
0.5 5.2 0.07 23.0
1 0.03* 0.6 76.4
2 4.6 0.5*
4 84.1*
8 10.2
>8 0.3
Total %
Susceptible
100% 89.5% 100%

FDA susceptible breakpoint.


MRSA MIC Distribution 2014:
% of isolates at MIC4

In vitro activity does not necessarily correlate with clinical results. Clinical trials did not establish that TEFLARO was statistically superior to vancomycin plus aztreonam.

MIC
(µg/mL)
Ceftaroline
(N=2258) MIC90=1
Vancomycin
(N=2258) MIC90=1
0.06 0 0
0.12 0.04 0
0.25 1.3 0.1
0.5 45 20.6
1 51.4* 78.2
2 2.3 1.1*
Total % Susceptible 97.7% 100%

FDA susceptible breakpoint.

MIC
(µg/mL)
Ceftaroline
(N=2258) MIC90=1
Vancomycin
(N=2258) MIC90=1
0.06 0 0
0.12 0.04 0
0.25 1.3 0.1
0.5 45 20.6
1 51.4* 78.2
2 2.3 1.1*
Total % Susceptible 97.7% 100%

FDA susceptible breakpoint.

Please click here for TEFLARO Indications and Usage and Important Safety Information.

Back to Top

 

U.S. Study Outline

AWARE is an ongoing worldwide surveillance program that began in 2008. The AWARE 2014 U.S. study surveyed the in vitro susceptibility activity of ceftaroline and other agents against methicillin-resistant Staphylococcus aureus, other Gram-positive and Gram-negative pathogens, including Streptococcus spp, Haemophilus spp, and Enterobacteriaceae. A total of 24,649 bacterial isolates were collected from 141 representative hospitals and medical centers distributed across all 9 U.S. Census regions from January to December 2014. Specimen type, infection site, classification of infection, and patient demographic information were documented for each bacterial isolate. Only clinically significant isolates were included, and only one isolate per patient was permitted. All body sites were considered acceptable clinical sources, and the majority came from blood (14.0%), respiratory specimens (27.6%), and skin (36.0%). The AWARE U.S. study is funded by Allergan, Inc.

This site provides a subset of data from the AWARE surveillance program. Listed here are the national and regional susceptibilities of ceftaroline and vancomycin against skin isolates of methicillin-resistant S. aureus (MRSA); ceftaroline and ceftriaxone against respiratory isolates of S. pneumoniae; and ceftaroline, ceftriaxone, and vancomycin against skin and respiratory isolates of methicillin-susceptible S. aureus (MSSA). In ceftaroline fosamil clinical trials, MRSA and MSSA were the most frequently identified skin pathogens in the CANVAS skin infection trials, and S. pneumoniae and MSSA were the most frequently identified respiratory pathogens in the FOCUS pneumonia trials.

Susceptibilty Testing and Interpretation

The collection and susceptibility testing of non-duplicate clinical isolates were carried out by a central laboratory (JMI Laboratories Inc.), utilizing broth microdilution susceptibility testing methods according to the Clinical and Laboratory Standards Institute (CLS) M100-525 (2015). Current breakpoints established by the FDA were used in interpreting ceftaroline susceptibility. In the tables where there are no FDA ceftaroline intermediate or resistant breakpoints available for the bacterial organisms listed, not applicable (N/A) was used. For ceftriaxone and vancomycin, CLS interpretative breakpoints were used. Tables and graphs shown in this AWARE 2014 susceptibility card focus on Staphylococcus aureus (both methicillin-susceptible and -resistant) and Streptococcus pneumoniae, since these were the most frequently identified organisms in skin infections and community-acquired pneumonia, respectively. These in vitro susceptibilities do not necessarily correlate with clinical outcomes.

Next: Adverse Reactions Profile

Pathogen Coverage

In ABSSSI, TEFLARO is the first and only cephalosporin with activity against MRSA

SEE PATHOGEN COVERAGE
INDICATIONS AND USAGE
  • TEFLARO® (ceftaroline fosamil) is indicated in adult and pediatric patients 2 months of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and ‑resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
  • TEFLARO is also indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Hypersensitivity Reactions

Clostridium difficile-Associated Diarrhea

Direct Coombs' Test Seroconversion

Development of Drug-Resistant Bacteria

Adverse Reactions in Adults

Adverse Reactions in Pediatrics

Drug Interactions

Use in Specific Populations

Please also see full Prescribing Information.

Show More

IMPORTANT SAFETY INFORMATION

Contraindications

  • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline.

Warnings and Precautions

Hypersensitivity Reactions

  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterial drugs. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been clearly established.
  • If an allergic reaction to TEFLARO occurs, discontinue TEFLARO and institute appropriate treatment and supportive measures.

Clostridium difficile-Associated Diarrhea

  • Clostridium difficile-Associated Diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.

Direct Coombs' Test Seroconversion

  • In adults, seroconversion from a negative to a positive direct Coombs' test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled adult Phase 3 trials.
  • In children, seroconversion from a negative to a positive direct Coombs' test result occurred in 42/234 (17.9%) of patients receiving TEFLARO and 3/93 (3.2%) of patients receiving comparator drugs in the three pooled pediatric trials.
  • No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.

Development of Drug-Resistant Bacteria

  • Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions in Adults

  • In the four pooled adult Phase 3 clinical trials, serious adverse reactions occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.
  • The most common adverse reactions occurring in >2% of patients receiving TEFLARO in the adult pooled Phase 3 clinical trials were diarrhea (5%) nausea (4%), and rash (3%).

Adverse Reactions in Pediatrics

  • In the three pooled pediatric clinical trials, serious adverse reactions occurred in 10/257 (4%) of patients receiving TEFLARO and 3/102 (3%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 10/257 (3.9%) of patients receiving TEFLARO and 2/102 (2%) of patients receiving comparator drugs with the most common adverse reaction leading to discontinuation being rash in 2/257 (0.8%) of patients treated with TEFLARO.
  • The most common adverse reactions occurring in ≥3% of patients receiving TEFLARO in the pooled pediatric clinical trials were diarrhea (8%), rash (7%), vomiting (5%), pyrexia (3%) and nausea (3%).

Drug Interactions

  • No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drug-drug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

Use in Specific Populations

  • There have been no adequate and well-controlled studies with TEFLARO in pregnant or nursing women. TEFLARO should only be used if the potential benefit justifies the potential risk in these populations.
  • Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available.
  • Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.
  • Dosage adjustment is required in adult patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min). There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 mL/min/1.73m2.
  • The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

Please also see full Prescribing Information.