Omadacycline Injection and Oral Products
FDA Identified Breakpoints for Omadacycline
For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
|
Minimum Inhibitory |
Disk Diffusion (zone |
||||
---|---|---|---|---|---|---|
Pathogen |
S |
I |
R |
S |
I |
R |
Enterobacteriaceae a,† |
≤4 |
8 |
≥ 16 |
≥18 |
16-17 |
≤15 |
Staphylococcus aureus (including |
≤ 0.5 |
1.0 |
≥ 2.0 |
≥ 21 |
19-20 |
≤18 |
Staphylococcus lugdunensis |
≤ 0.12 |
0.25 |
≥0.5 |
≥ 29 |
26-28 |
≤25 |
Enterococcus faecalis |
≤ 0.25 |
0.5 |
≥ 1.0 |
≥18 |
16-17 |
≤15 |
Streptococcus anginosus group b |
≤ 0.12 |
0.25 |
≥ 0.5 |
≥ 24 |
18-23 |
≤17 |
Streptococcus pyogenes |
≤ 0.12 |
0.25 |
≥ 0.5 |
≥19 |
16-18 |
≤15 |
S = Susceptible; I = Intermediate; R = Resistant
† Omadacycline is not active in vitro against Morganella spp., Proteus spp., and Providencia spp.
aKlebsiella pneumoniae and Enterobacter cloacae only
bStreptococcus anginosus group includes S. anginosus, S. intermedius, and S. constellatus
For Community Acquired Bacterial Pneumonia (CABP)
|
Minimum Inhibitory |
Disk Diffusion (zone |
||||
---|---|---|---|---|---|---|
Pathogen |
S |
I |
R |
S |
I |
R |
Enterobacteriaceae a,† |
≤4 |
8 |
≥ 16 |
≥18 |
16-17 |
≤15 |
Staphylococcus aureus (methicillin- susceptible isolates only) |
≤ 0.25 |
0.5 |
≥ 1.0 |
≥ 23 |
21-22 |
≤20 |
Haemophilus species b |
≤2 |
4 |
≥ 8 |
≥ 20 |
17-19 |
≤16 |
Streptococcus pneumoniae |
≤0.12 |
0.25 |
≥ 0.5 |
≥25 |
23-24 |
≤22 |
S = Susceptible; I = Intermediate; R = Resistant
† Omadacycline is not active in vitro against Morganella spp., Proteus spp., and Providencia spp.
aKlebsiella pneumoniae only
bHaemophilus species includes H. influenzae and H. parainfluenzae