Melinta Medical Affairs

 

Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis..
Antimicrob Agents Chemother. 2024;68(5):e0158423.

Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials.
Lancet Infect Dis. 2024 Mar;24(3):319-328.

Phase I study of the pharmacokinetics and safety of rezafungin in subjects with moderate/severe hepatic impairment and matched control subjects.
Pharmacotherapy. 2024 Jun;44(6):435-443. doi: 10.1002/phar.2943. Epub 2024 Jun 5.

Efficacy and Safety of Rezafungin and Caspofungin in Candidaemia and Invasive Candidiasis: Pooled Data from Two Prospective Randomised Controlled Trials.
Lancet Infect Dis. 2023; S1473-3099(23)00551-0.

Registrational and Pivotal Trial Data

Rezafungin Versus Caspofungin for Treatment Of Candidaemia and Invasive Candidiasis (ReSTORE): A Multicenter, Double-Blind, Double-Dummy, Randomised Phase 3 Trial.
Lancet. 2023;401:49-59.

Efficacy and Safety of Rezafungin and Caspofungin in Candidaemia and Invasive Candidiasis: Pooled Data from Two Prospective Randomised Controlled Trials.
Lancet Infect Dis. 2023; S1473-3099(23)00551-0.

Rezafungin Versus Caspofungin in A Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial.
Clin Infect Dis. 2021;73(11):e3647-55.

In Vitro Microbiology and Pharmacology Studies

Population Pharmacokinetic Modeling and Target Attainment Analyses of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis..
Antimicrob Agents Chemother. 2023 Dec 14;67(12):e0091623

In Vitro Activity of Rezafungin Against Common and Rare Candida Species and Saccharomyces cerevisiae.
J Antimicrob Chemother. 2019;74(12):3505-3510

Activity Of CD101, A Long-Acting Echinocandin, Against Clinical Isolates of Candida auris.
Diagn Microbiol Infect Dis. 2018;90(3):196-197

Absence of Clinically Meaningful Drug-Drug Interactions with Rezafungin: Outcome of Investigations.
Microbiol Spectr. 2023;11(3):e0133923

Population Pharmacokinetics of Rezafungin in Patients with Fungal Infections.
Antimicrob Agents Chemother. 2021;65(11):e0084221

Lack of Effect of Rezafungin on QT/Qtc Interval in Healthy Subjects.
Clin Pharmacol Drug Dev. 2020;9(4):456-465

Population Pharmacokinetic Analyses for Rezafungin (CD101) Efficacy Using Phase 1 Data.
Antimicrob Agents Chemother. 2018;62(6):e02603-17.

Safety and Pharmacokinetics of CD101 IV, a Novel Echinocandin, in Healthy Adults.
Antimicrob Agents Chemother. 2017;61(2):e01627-16.

Metabolism, Excretion, and Mass Balance of [14C]-Rezafungin in Animals and Humans.
Antimicrob Agents Chemother. 2018;66(1):e0139021

Review Articles

Rezafungin: First Approval.
Drugs. 2023;83(9):833-840

Registrational and Pivotal Trial Data

Effect of Meropenem-Vaborbactam vs Piperacillin-Tazobactam on Clinical Cure or Improvement and Microbial Eradication in Complicated Urinary Tract Infection: The TANGO I Randomized Clinical Trial.
JAMA. 2018;319(8):788-799.

Effect and Safety of Meropenem-Vaborbactam versus Best-Available Therapy in Patients with Carbapenem-Resistant Enterobacteriaceae Infections: The TANGO II Randomized Clinical Trial.
Infect Dis Ther. 2018;7(4):439-455.

Efficacy and Safety of Meropenem-Vaborbactam Versus Best Available Therapy for the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections in Patients Without Prior Antimicrobial Failure: A Post Hoc Analysis.
Adv Ther. 2019;36(7):1771-1777.

Clinical Outcomes of Patient Subgroups in the TANGO II Study.
Infect Dis Ther. 2021;10(1):35-46

In Vitro Microbiology and Pharmacology Studies

Meropenem-Vaborbactam Activity against U.S. Multidrug-Resistant Enterobacterales Strains, Including Carbapenem-Resistant Isolates.
Microbiol Spectr. 2023;11(1):e0450722.

Pharmacokinetic-Pharmacodynamic Target Attainment Analyses as Support for Meropenem-Vaborbactam Dosing Regimens and Susceptibility Breakpoints.
Antimicrob Agents Chemother. 2022;66(12):e0213021

Meropenem-vaborbactam activity against carbapenem-resistant Enterobacterales isolates collected in U.S. hospitals during 2016 to 2018.
Antimicrob Agents Chemother. 2020;64(3):e02177-19.

In vitro Evaluation of Meropenem-Vaborbactam Against Clinical CRE Isolates at a Tertiary Care Center with Low KPC-Mediated Carbapenem Resistance.
Diagn Microbiol Infect Dis. 2019;93(3):258-260

Pharmacokinetics/Pharmacodynamics of Vaborbactam, A Novel Beta-Lactamase Inhibitor, In Combination with Meropenem.
Antimicrob Agents Chemother. 2018;63(1):e01659-18.

In Vitro  Activity of Meropenem-Vaborbactam against Clinical Isolates of KPC-Positive Enterobacteriaceae.
Antimicrob Agents Chemother. 2017;62(1):e01904-17.

Activity of Simulated Human Dosage Regimens of Meropenem and Vaborbactam against Carbapenem-Resistant Enterobacteriaceae in an In Vitro Hollow-Fiber Model.
Antimicrob Agents Chemother. 2018;62(2):e01969-17.

Review Articles

An Appraisal of the Pharmacokinetic and Pharmacodynamic Properties of Meropenem-Vaborbactam.
Infect Dis Ther. 2020;9(4):769-784.

Real-World Studies and Analyses

Infectious Diseases Society of America 2023 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections.
Clin Infect Dis. 2023 Jul 18:ciad428.

Registrational and Pivotal Trial Data

Kimyrsa, an Oritavancin-Containing Product: Clinical Study and Review of Properties.
Open Forum Infect Dis. 2022;9(5):ofac090

Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO studies.
Antimicrob Agents Chemother. 2018;62(4):e01919-17

Single-Dose Oritavancin in the Treatment of Acute Bacterial Skin Infections.
N Engl J Med. 2014;370(23):2180-90

Single-Dose Oritavancin versus 7-10 days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study.
Clin Infect Dis. 2015;60(2):254-62

In Vitro Microbiology and Pharmacology Studies

Population Pharmacokinetic Analysis for a Single 1,200-milligram Dose of Oritavancin using data from Two Pivotal Phase 3 Clinical Trials.
Antimicrob Agents Chemother. 2015;59(6):3365-72

Review Articles

Oritavancin (KIMYRSA™) in Acute Bacterial Skin and Skin Structure Infections: A Profile of its Use in the USA.
Drugs & Therapy Perspectives. 2022;38:57-63

Real-World Studies and Analyses

Comparison of Inpatient Standard-of-Care to Outpatient Oritavancin Therapy for Patients with Acute Uncomplicated Cellulitis.
J Pharm Pract. 2021;36(1):27-32

Improved Economic and Clinical Outcomes with Oritavancin versus a Comparator Group for Treatment of Acute Bacterial Skin and Skin Structure Infections in a Community Hospital.
PLoS One. 2021;16(3):e0248129

Early directed Oritavancin therapy in the Emergency Department may lead to Hospital Avoidance compared to Standard Treatment for Acute Bacterial Skin and Skin Structure Infections: A Real-World Retrospective Analysis.
Drugs Real World Outcomes. 2020;7:20-29

Expediting Discharge in Hospitalized, Adult Patients with Skin and Soft Tissue Infections who received Empiric Vancomycin Therapy with Oritavancin: Description of Findings from an Institutional Pathway.
Drugs Real World Outcomes. 2020;7:30-35

Comparisons of 30-Day Admission and 30-Day Total Healthcare Costs between patients who were Treated with Oritavancin or Vancomycin for a Skin Infection in the Outpatient setting.
Open Forum Infect Dis. 2019;6(12):ofz475

 

Pharmacokinetic and Pharmacodynamic Profiling of Minocycline for Injection Following a Single Infusion in Critically Ill Adults in a Phase IV Open-Label Multicenter Study (ACUMIN).
Antimicrob Agents Chemother. 2021;65(3):e01809-20.

Registrational and Pivotal Trial Data

A Phase 3 Study to Compare Delafloxacin with Moxifloxacin for the Treatment of Adults with Community-Acquired Bacterial Pneumonia (DEFINE-CABP).
Open Forum Infect Dis. 2019;7(1):ofz514.

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.
Antimicrob Agents Chemother. 2020;97:374-379.

A Randomized, Double-Blind, Phase 2 Study to Evaluate Subjective and Objective Outcomes in Patients with Acute Bacterial Skin and Skin Structure Infections Treated with Delafloxacin, Linezolid or Vancomycin.
J Antimicrob Chemother. 2016;71(3):821-9.

Analysis of Pooled Phase 3 Safety Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.
Clin Infect Dis. 2019;68(Suppl 3):S233-S240.  

Analysis of Pooled Phase III Efficacy Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.
Clin Infect Dis. 2019;68(Suppl 3):S223-S232.

Efficacy of Delafloxacin Versus Moxifloxacin against Atypical Bacterial Respiratory Pathogens in Adults with Community-Acquired Bacterial Pneumonia (CABP): Data from the Delafloxacin Phase 3 CABP Trial.
Int J Infect Dis. 2020;97:374-379.  

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.
Clin Infect Dis. 2018;67(5):657-666.  

In Vitro Microbiology and Pharmacology Studies

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.

Review Articles

Delafloxacin: A Review in Community-Acquired Pneumonia.
Drugs. 2022;82(8):913-923.  

Community-Acquired Bacterial Pneumonia-Changing Epidemiology, Resistance Patterns, and Newer Antibiotics: Spotlight on Delafloxacin.
Clin Drug Investig. 2020;40(10):947-960.

Delafloxacin: A Review in Acute Bacterial Skin and Skin Structure Infections.
Drugs. 2020;80(12):1247-1258.  

Real-World Studies and Analyses

Update on the Activity of Delafloxacin against Acute Bacterial Skin and Skin-Structure Infection Isolates from European Hospitals (2014-2019).
J Glob Antimicrob Resist. 2020;23:278-283.

Comparative Efficacy of Delafloxacin for Complicated and Acute Bacterial Skin and Skin Structure Infections: Results from a Network Meta-Analysis.
BMC Infect Dis. 2021;21:1036.