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  1. Development Resources

Delafloxacin Injection and Oral Products

FDA Identified Breakpoints

For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

  Minimum Inhibitory
Concentrations
(mcg/mL)
Disk Diffusion
(zone diameter in mm)
Pathogen S I R S I R
Staphylococcus aureus
(methicillin-resistant and
methicillin-susceptible
isolates)
≤ 0.25 0.5 ≥ 1 ≥ 23 20-22 ≤ 19
Staphylococcus
haemolyticus
≤ 0.25 0.5 ≥ 1 ≥ 24 21-23 ≤ 20
Streptococcus pyogenesa ≤ 0.06 - - ≥ 20 - -
Streptococcus agalactiae ≤ 0.06 0.12 ≥ 0.25   -  
Streptococcus anginosusGroupa, b ≤ 0.06 - - ≥ 25 - -
Enterococcus faecalis ≤ 0.12 0.25 ≥ 0.5 ≥ 21 19-20 ≤ 18
Enterobacteriaceae c ≤ 0.25 0.5 ≥ 1 ≥22 19-21 ≤ 18
Pseudomonas aeruginosa ≤ 0.5 1 ≥ 2 ≥23 20-22 ≤ 19

S = Susceptible; I = Intermediate; R = Resistant
For disk diffusion, use paper disks impregnated with 5 mcg delafloxacin

aThe current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC results other than “Susceptible” should be submitted to a reference laboratory for further testing.
b includes: S. anginosus, S. constellatus and S. intermedius
c E. coli, K. pneumoniae, and E. cloacae only.

For Community Acquired Bacterial Pneumonia (CABP)

 

Minimum Inhibitory
Concentrations
(mcg/mL)

Disk Diffusion
(zone diameter in mm)

Pathogen

S

I

R

S

I

R

Streptococcus pneumoniae*

≤0.03 --- --- ND ND ND

Staphylococcus aureus (methicillin-susceptible isolates)

≤0.12 0.25 ≥0.5 ≥25 21-24 ≤20

Haemophilus influenzae*

≤0.004 --- --- ≥29 --- ---

Haemophilus parainfluenzae*

≤0.06 --- --- ≥28 --- ---

Escherichia coli

≤0.25 0.5 ≥1 ≥22 19-21 ≤18

Klebsiella pneumoniae

≤0.25 0.5 ≥1 ≥22 19-21 ≤18

Pseudomonas aeruginosa

≤0.5 1 ≥2 ≥23 20-22 ≤19

S = Susceptible; I = Intermediate; R = Resistant; ND = not determined
For disk diffusion, use paper disks impregnated with 5 mcg delafloxacin

*The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC results other than “Susceptible” should be submitted to a reference laboratory for further testing.