Breakpoints (mg/L) of delafloxacin for organisms causing acute bacterial skin and skin structure infections (ABSSSI)
| Pathogen . | FDAa . | EUCAST (EMA)b . | |||
|---|---|---|---|---|---|
| Sc . | I . | R . | S . | R . | |
| Staphylococcus aureusd | ≤0.25 | 0.5 | ≥1 | ≤0.25 | >0.25 |
| Staphylococcus haemolyticus | ≤0.25 | 0.5 | ≥1 | ||
| Staphylococcus lugdunensis | ≤0.03 | e | e | ||
| Streptococcus groups A, B, C and G | ≤0.03 | >0.03 | |||
| Streptococcus pyogenes | ≤0.03 | e | e | ||
| Streptococcus agalactiae | ≤0.06 | 0.12 | ≥0.25 | ||
| Streptococcus anginosus groupf | ≤0.06 | e | e | ≤0.03 | >0.03 |
| Enterococcus spp. | IEg | IE | |||
| Enterococcus faecalis | ≤0.12 | 0.25 | ≥0.5 | ||
| Viridans group | ≤0.03 | >0.03 | |||
| Enterobacteralesh,i | ≤0.25 | 0.5 | ≥1 | ≤0.125 | >0.125 |
| Pseudomonas aeruginosa | ≤0.5 | 1 | ≥2 | IE | IE |
| Pathogen . | FDAa . | EUCAST (EMA)b . | |||
|---|---|---|---|---|---|
| Sc . | I . | R . | S . | R . | |
| Staphylococcus aureusd | ≤0.25 | 0.5 | ≥1 | ≤0.25 | >0.25 |
| Staphylococcus haemolyticus | ≤0.25 | 0.5 | ≥1 | ||
| Staphylococcus lugdunensis | ≤0.03 | e | e | ||
| Streptococcus groups A, B, C and G | ≤0.03 | >0.03 | |||
| Streptococcus pyogenes | ≤0.03 | e | e | ||
| Streptococcus agalactiae | ≤0.06 | 0.12 | ≥0.25 | ||
| Streptococcus anginosus groupf | ≤0.06 | e | e | ≤0.03 | >0.03 |
| Enterococcus spp. | IEg | IE | |||
| Enterococcus faecalis | ≤0.12 | 0.25 | ≥0.5 | ||
| Viridans group | ≤0.03 | >0.03 | |||
| Enterobacteralesh,i | ≤0.25 | 0.5 | ≥1 | ≤0.125 | >0.125 |
| Pseudomonas aeruginosa | ≤0.5 | 1 | ≥2 | IE | IE |
US FDA Recognized Antimicrobial Susceptibility Test Interpretive Criteria.
EUCAST [acting under Standard Operating Procedures (SOP) for the EMA].
S, susceptible; I, intermediate; R, resistant [FDA and EUCAST; see detailed definition in (i) Document M100 (Performance Standards for Antimicrobial Susceptibility Testing) of the CLSI for the FDA and (ii) EUCAST documentation (EUCAST; no I category set for delafloxacin essentially because the approved dosage is fixed)].
Methicillin-resistant and methicillin-susceptible isolates.
For the FDA, 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.
For FDA: this includes S. anginosus, S. constellatus and S. intermedius.
IE (EUCAST): insufficient evidence that the organism or group is a good target for therapy with the agent.
New nomenclature for Enterobacteriaceae.
For FDA: E. coli, K. pneumoniae, and E. cloacae only; for EUCAST: E coli only.
Breakpoints (mg/L) of delafloxacin for organisms causing acute bacterial skin and skin structure infections (ABSSSI)
| Pathogen . | FDAa . | EUCAST (EMA)b . | |||
|---|---|---|---|---|---|
| Sc . | I . | R . | S . | R . | |
| Staphylococcus aureusd | ≤0.25 | 0.5 | ≥1 | ≤0.25 | >0.25 |
| Staphylococcus haemolyticus | ≤0.25 | 0.5 | ≥1 | ||
| Staphylococcus lugdunensis | ≤0.03 | e | e | ||
| Streptococcus groups A, B, C and G | ≤0.03 | >0.03 | |||
| Streptococcus pyogenes | ≤0.03 | e | e | ||
| Streptococcus agalactiae | ≤0.06 | 0.12 | ≥0.25 | ||
| Streptococcus anginosus groupf | ≤0.06 | e | e | ≤0.03 | >0.03 |
| Enterococcus spp. | IEg | IE | |||
| Enterococcus faecalis | ≤0.12 | 0.25 | ≥0.5 | ||
| Viridans group | ≤0.03 | >0.03 | |||
| Enterobacteralesh,i | ≤0.25 | 0.5 | ≥1 | ≤0.125 | >0.125 |
| Pseudomonas aeruginosa | ≤0.5 | 1 | ≥2 | IE | IE |
| Pathogen . | FDAa . | EUCAST (EMA)b . | |||
|---|---|---|---|---|---|
| Sc . | I . | R . | S . | R . | |
| Staphylococcus aureusd | ≤0.25 | 0.5 | ≥1 | ≤0.25 | >0.25 |
| Staphylococcus haemolyticus | ≤0.25 | 0.5 | ≥1 | ||
| Staphylococcus lugdunensis | ≤0.03 | e | e | ||
| Streptococcus groups A, B, C and G | ≤0.03 | >0.03 | |||
| Streptococcus pyogenes | ≤0.03 | e | e | ||
| Streptococcus agalactiae | ≤0.06 | 0.12 | ≥0.25 | ||
| Streptococcus anginosus groupf | ≤0.06 | e | e | ≤0.03 | >0.03 |
| Enterococcus spp. | IEg | IE | |||
| Enterococcus faecalis | ≤0.12 | 0.25 | ≥0.5 | ||
| Viridans group | ≤0.03 | >0.03 | |||
| Enterobacteralesh,i | ≤0.25 | 0.5 | ≥1 | ≤0.125 | >0.125 |
| Pseudomonas aeruginosa | ≤0.5 | 1 | ≥2 | IE | IE |
US FDA Recognized Antimicrobial Susceptibility Test Interpretive Criteria.
EUCAST [acting under Standard Operating Procedures (SOP) for the EMA].
S, susceptible; I, intermediate; R, resistant [FDA and EUCAST; see detailed definition in (i) Document M100 (Performance Standards for Antimicrobial Susceptibility Testing) of the CLSI for the FDA and (ii) EUCAST documentation (EUCAST; no I category set for delafloxacin essentially because the approved dosage is fixed)].
Methicillin-resistant and methicillin-susceptible isolates.
For the FDA, 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.
For FDA: this includes S. anginosus, S. constellatus and S. intermedius.
IE (EUCAST): insufficient evidence that the organism or group is a good target for therapy with the agent.
New nomenclature for Enterobacteriaceae.
For FDA: E. coli, K. pneumoniae, and E. cloacae only; for EUCAST: E coli only.
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