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ABSSSI Microbiological Activity

BAXDELA® (delafloxacin) ABSSSI Microbiological Eradication Rates

Pathogen eradication was a prespecified exploratory analysis in BAXDELA Phase 3 ABSSSI trials.

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

BAXDELA achieved eradication against MRSA and MSSA, including 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 (1 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 eradication against susceptible gram-negative pathogens

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
0.03 100% (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).
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
0.12 100% (2/2)
0.25 100% (4/4)
0.5 100% (2/2)
1 100% (1/1)
4 100% (2/2)

aDocumented or presumed eradicated, microbiologically evaluable population.
Data on file. Melinta Therapeutics, LLC.

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.

Four 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
  • ETEST® Delafloxacin from bioMérieux

Next: Mechanism of Action

INDICATION & USAGE:

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

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Medical Information
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www.melintamedicalinformation.com

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BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.