Microbiological Activity

BAXDELA Microbiological Eradication Rates

Microbiologic Responsea at Follow-up Visit (Day 14 +/− 1) Pooled data from phase 3 trials

BAXDELA achieved high eradication rates against susceptible gram-positive pathogens as well as fluoroquinolone-nonsusceptible strains

Baseline MIC
(µg/mL)
Eradicateda
N=106
0.004 100% (3/3)
0.008 96.7% (29/30)
0.015 100% (3/3)
0.06 100% (1/1)
0.12 100% (32/32)*
0.25 97.2% (35/36)*
0.5 100% (2/2)*
4 100% (1/1)*
*Fluoroquinolone-nonsusceptible MRSA; delafloxacin MIC range 0.12-4 µg/mL; 70/71 documented or presumed eradicated (one presumed persisted with an MIC of 0.25 µg/mL)
Baseline MIC
(µg/mL)
Eradicateda
N=140
0.002 100% (15/15)
0.004 100% (41/41)
0.008 97.2% (70/72)
0.015 100% (4/4)
0.03 100% (3/3)*
0.12 100% (6/6)*
0.5 100% (1/1)*
*Fluoroquinolone-nonsusceptible MSSA; delafloxacin MIC range 0.03-0.5 µg/mL; 10/10 documented or presumed eradicated

MIC = minimum inhibitory concentration.
aDocumented or presumed eradicated, microbiologically evaluable population.
McCurdy S, Lawrence L, Quintas M, et al. In vitro activity of delafloxacin and microbiological response against fluoroquinolone-susceptible and nonsusceptible Staphylococcus aureus isolates from two phase 3 studies of acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2017;61(9):e00772-​17.

BAXDELA achieved high eradication rates against susceptible gram-negative pathogens

Baseline MIC
(µg/mL)
Eradicateda
N=17
0.03 100% (3/3)
0.06 100% (2/2)
0.12 100% (8/8)
0.25 100% (3/3)
4 100% (1/1)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.008 100% (1/1)
0.015 100% (1/1)
0.03 100% (5/5)
0.06 100% (2/2)
1 100% (1/1)
2 100% (1/1)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.12 100% (2/2)
0.25 100% (4/4)
0.5 100% (2/2)
1 100% (1/1)
4 100% (2/2)
Baseline MIC
(µg/mL)
Eradicateda
N=11
0.03 100% (1/1)
0.06 100% (4/4)
0.12 100% (5/5)
2 0% (0/1)
4 100% (1/1)
Note: One E cloacae isolate persisted (MIC of 2 μg/mL).

aDocumented or presumed eradicated, microbiologically evaluable population.
Data on file (included in BAXDELA New Drug Application). Melinta Therapeutics, Inc.; 2016.

Test methods and criteria

For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please visit https://www.fda.gov/STIC.

Three susceptibility testing devices are available for BAXDELA

For more information on these tests, please click here or contact your local representative.

  • Delafloxacin Susceptibility Disk Available from Hardy Diagnostics
  • Delafloxacin MIC Test Strip Available from Liofilchem
  • Delafloxacin Sensititre™ susceptibility MIC plates from ThermoFisher Scientific
BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.