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
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