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P-103. Landscape of Post-Marketing Requirements under the Pediatric Research Equity Act for Antibiotics from 2009-2024 Open
Background We reviewed Post-Marketing Requirements (PMRs) under the Pediatric Research Equity Act (PREA) for antibiotics approved in adults from 2009 to 2024 indicated for acute bacterial skin and structural infections (ABSSSI), community-…
Landscape of Post-Marketing Requirements Under the Pediatric Research Equity Act for Antibiotics from 2009–2024 Open
Background/Objectives: We reviewed Post-Marketing Requirements (PMRs) under the Pediatric Research Equity Act (PREA) for antibiotics approved in adults from 2009 to 2024 to better understand factors associated with PMR study completion. Me…
Modeling the Impact of Antimicrobial Resistance on Medical Preparedness and Response for a Nuclear or Radiological Public Health Emergency Open
Objective Antimicrobial resistant infections are expected to increase the rate of antibiotic treatment failure in patients during a mass casualty incident. We aim to examine the potential impact of rising antimicrobial resistance (AMR) on …
View article: US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary—Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea
US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary—Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea Open
There is an unmet need for developing drugs for the treatment of gonorrhea due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug-resista…
Pharmacokinetic-Pharmacodynamic Target Attainment Analyses as Support for Meropenem-Vaborbactam Dosing Regimens and Susceptibility Breakpoints Open
Meropenem-vaborbactam is a fixed-dose beta-lactam/beta-lactamase inhibitor with potent in vitro and in vivo activity against Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacterales . Pharmacokinetic-pharmacodynamic (PK-PD) tar…
Serotype distribution and antimicrobial susceptibility of <i>Streptococcus pneumoniae</i> isolates from a Phase III community-acquired bacterial pneumonia (CABP) trial Open
Objectives To report Streptococcus pneumoniae serotyping and susceptibility data from a recent clinical trial (ML-3341-306) comparing delafloxacin with moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia (CA…
Efficacy of Delafloxacin versus Moxifloxacin against Bacterial Respiratory Pathogens in Adults with Community-Acquired Bacterial Pneumonia (CABP): Microbiology Results from the Delafloxacin Phase 3 CABP Trial Open
Delafloxacin is a novel fluoroquinolone with activity against Gram-positive, Gram-negative, and atypical pathogens, including fluoroquinolone-nonsusceptible methicillin-resistant Staphylococcus aureus (MRSA). The microbiological results of…
A Phase-3 Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults with Community-acquired Bacterial Pneumonia (DEFINE-CABP) Open
Background The clinical and economic burden of community-acquired bacterial pneumonia (CABP) is significant and is anticipated to increase as the population ages and pathogens become more resistant. Delafloxacin is a fluoroquinolone antibi…
2228. Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Patients with Diabetes: Outcomes from a Global Phase 3 Study of Delafloxacin (DLX) Open
Background Delafloxacin (DLX) is an IV/oral anionic fluoroquinolone with no QT restrictions. It is approved for the treatment of serious skin infections including those due to MRSA and Gram-negative pathogens. A Phase 3 trial of patients w…
470. Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in Patients with Significant Drug Abuse: Outcomes from Global Phase 3 Studies of Delafloxacin (DLX) Open
Background Delafloxacin (DLX), an IV/oral anionic fluoroquinolone antibiotic, is approved for the treatment of ABSSSI including those due to MRSA and Gram-negative pathogens including P. aeruginosa. Two global phase 3 ABSSSI trials include…
2234. Outcomes by Age and Gender from a Global Phase 3 Study of Delafloxacin (DLX) in Community-Acquired Bacterial Pneumonia (CABP) Open
Background Delafloxacin (DLX) is a fluoroquinolone, approved in the United States for treatment of ABSSSI. DLX has no preclinical signals for QT prolongation and has no QT prolongation in a validated challenge study. Risk of QT prolongatio…
2232. A Global Phase 3 Study of Delafloxacin (DLX) Compared with Moxifloxacin (MOX) in Patients with Community-acquired Bacterial Pneumonia (CABP) Open
Background DLX is an IV/oral fluoroquinolone with no QT restrictions, and activity against Gram-positive, Gram-negative and atypical pathogens. DLX is approved for treatment of ABSSSI including those due to MRSA and Gram-negative pathogens…
Analysis of Pooled Phase III Efficacy Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections Open
Overall, IV/oral delafloxacin fixed-dose monotherapy was non-inferior to IV vancomycin/aztreonam combination therapy and was well tolerated in each Phase III study, as well as in the pooled analysis, regardless of endpoint or analysis popu…
View article: 1387. Phase I Study to Evaluate the Safety and Pharmacokinetics (PK) of Single and Multiple Ascending Doses (SAD/MAD) of Intravenous (IV) Minocycline in Healthy Adult Subjects
1387. Phase I Study to Evaluate the Safety and Pharmacokinetics (PK) of Single and Multiple Ascending Doses (SAD/MAD) of Intravenous (IV) Minocycline in Healthy Adult Subjects Open
Background Carbapenem-resistant Acinetobacter baumannii infections are defined by the WHO as a critical threat. IV minocycline is approved in the United States for treatment of Acinetobacter infections at doses up to 200 mg BID. This study…
2378. Resolution of Signs and Symptoms (S&S) of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) With Delafloxacin (DLX) IV/Oral Therapy Open
BACKGROUND: Delafloxacin, a fluoroquinolone antibiotic with Gram-negative and Gram-positive activity including MRSA, was approved for treatment of ABSSSI. In a phase 3 ABSSSI trial, DLX was non-inferior to VAN/AZ in both objective and clin…
2377. Outcomes in Patients With History of Cardiac or Vascular Disease (CV) During Treatment of Acute Bacterial Skin And Skin Structure Infection (ABSSSI) With Delafloxacin (DLX) vs. Vancomycin/Aztreonam (VAN/AZ) Open
BACKGROUND: DLX, an anionic fluoroquinolone antibiotic with Gram-positive and Gram-negative activity, was recently approved for treatment of ABSSSI. Two global phase 3 ABSSSI trials (studies 302 and 303) included patients with cardiac or v…
Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Open
If disease groups and patient characteristics in future studies produce an ACM rate so low (<10%-15%) that a fixed noninferiority margin of 10% cannot be justified (requiring an odds ratio analysis), an ACM+ endpoint could lower sample siz…
Safety of Delafloxacin: Focus on Adverse Events of Special Interest Open
Background Fluoroquinolones have been widely used for a variety of Gram-positive and Gram-negative infections, and by 2002 they had become the most commonly prescribed class of antibiotics for adults in the United States. With widespread u…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
Lack of phototoxicity potential with delafloxacin in healthy male and female subjects: comparison to lomefloxacin Open
200 and 400 mg of delafloxacin administered for 6 days were well tolerated in healthy adult volunteers. Delafloxacin and placebo failed to demonstrate a phototoxic effect but lomefloxacin, the positive control, demonstrated moderate photot…
Clinical Pharmacokinetics of Sulfobutylether‐β‐Cyclodextrin in Patients With Varying Degrees of Renal Impairment Open
Delafloxacin, a fluoroquinolone, has activity against Gram‐positive organisms including methicillin‐resistant S aureus and fluoroquinolone‐susceptible and ‐resistant Gram‐negative organisms. The intravenous formulation of delafloxacin cont…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study
A Comparison of the Efficacy and Safety of Intravenous Followed by Oral Delafloxacin With Vancomycin Plus Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections: A Phase 3, Multinational, Double-Blind, Randomized Study Open
NCT01984684.
Delafloxacin Pharmacokinetics in Subjects With Varying Degrees of Renal Function Open
Delafloxacin, a fluoroquinolone, has activity against gram‐positive organisms including methicillin‐resistant Staphylococcus aureus and fluoroquinolone‐susceptible and –resistant gram‐negative organisms. This study was conducted to determi…
Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study Open
Delafloxacin, an anionic fluoroquinolone, was statistically non-inferior to vancomycin/aztreonam at 48-72 h following the start of therapy and was well tolerated as monotherapy in the treatment of acute bacterial skin and skin structure in…
<i>In Vitro</i> 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 Open
Delafloxacin is an investigational anionic fluoroquinolone antibiotic with broad-spectrum in vitro activity, including activity against Gram-positive organisms, Gram-negative organisms, atypical organisms, and anaerobes. The in vitro activ…
The Pharmacokinetics of the CYP3A Substrate Midazolam After Steady-state Dosing of Delafloxacin Open
Steady-state dosing of delafloxacin produced no significant changes in midazolam pharmacokinetics, except for a small but not clinically relevant change in the Cmax of 1-hydroxymidazolam. ClinicalTrials.gov identifier: NCT02505997.