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.
a Klebsiella pneumoniae and Enterobacter cloacae only
b Streptococcus 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.
a Klebsiella pneumoniae only
b Haemophilus species includes H. influenzae and H. parainfluenzae