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
Staphylococcus lugdunensisaa	≤ 0.03	-	-	≥ 31	-	-
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
Enterobacteralesc	≤ 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

^a 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.
^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

*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.