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Nabriva Corporate
  • Home
  • About Nabriva
    • Our Products
    • Named Patient Program
    • Meet the Team
  • pipeline & research
    • Fosfomycin
    • pleuromutilins
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News & Publications

Home / News & Publications

News & Publications

Stay up to date on what’s happening at Nabriva Therapeutics now. Here you’ll find downloadable versions of our poster presentations and published articles on our latest research insights.

To view our latest Nabriva Therapeutics press releases, click here

  • Posters
  • Publications

Posters

AAFP Conference

AAFP 2021

(PDF, 653KB)

Lefamulin (Pleuromutilin-Class Antibiotic) Is an Empiric, Monotherapeutic Treatment Option for Community-Acquired Bacterial Pneumonia Caused by Streptococcus pneumoniae, Including Drug-Resistant Strains

(PDF, 569KB)

A Multi-center Evaluation of the US Prevalence and Regional Variation in Macrolide-resistant Streptococcus pneumoniae from Blood or Respiratory Cultures Among Adult Patients

AANP National Conference

AANP 2021

(PDF, 653KB)

Lefamulin (Pleuromutilin-Class Antibiotic) Is an Empiric, Monotherapeutic Treatment Option for Community-Acquired Bacterial Pneumonia Caused by Streptococcus pneumoniae, Including Drug-Resistant Strains

(PDF, 569KB)

A Multi-center Evaluation of the US Prevalence and Regional Variation in Macrolide-resistant Streptococcus pneumoniae from Blood or Respiratory Cultures Among Adult Patients

ASM/ESCMID Conference on Drug Development to meet the Challenge of Antimicrobial Resistance

ASM/ESCMID 2019

(PDF, 2MB)

Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Efficacy Based on Data From Lefamulin-Treated Patients Enrolled in Phase 3 Studies for Community-Acquired Bacterial Pneumonia (CABP)

(PDF, 2MB)

Pharmacokinetic-Pharmacodynamic (PK-PD) Analyses for Alanine Aminotransferase (ALT) Using Phase 2 and 3 Data From Lefamulin-Treated Patients

(PDF, 2MB)

Lefamulin Activity Against Gram-Positive PathogensCollected in the 2017 Global SENTRY Antimicrobial Surveillance Program

American Society For Microbiology (ASM) MICROBE

ASM MICROBE 2019

(PDF, 2MB)

Lefamulin Activity Against Bacterial Pathogens Commonly Associated With Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) Collected in the 2017 Global SENTRY Antimicrobial Surveillance Program

(PDF, 595KB)

Lefamulin Activity Against Respiratory Tract Pathogens Collected in the 2017 Global SENTRY Antimicrobial Surveillance Program

(PDF, 2MB)

Efficacy of Lefamulin (LEF) Versus Moxifloxacin (MOX) by Pathogen in Adults With Community-Acquired Bacterial Pneumonia (CABP): Pooled Results From the LEAP 1 and LEAP 2 Phase 3 Clinical Trials

(PDF, 392KB)

Fosfomycin for Injection (FOS) Versus (vs) Piperacillin-Tazobactam (PIP-TAZ) for Treating Complicated Urinary Tract Infections (cUTI) and Acute Pyelonephritis (AP): Further Analyses of the ZEUS Study

ASM MICROBE 2018

(PDF, 468KB)

Lefamulin Is Non-inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): The Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 386KB)

Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 234KB)

Correlation of High-Risk Antibiotic Use and Hospital-Associated C. difficile Infections: Data From 195 US Hospitals

(PDF, 299KB)

A Multicenter Evaluation of Pathogen Distribution in Patients Admitted With Microbiologically-Confirmed Community-Acquired Bacterial Pneumonia (CABP) in the

(PDF, 399KB)

Molecular Characterization of Resistance Mechanisms Associated With Pleuromutilins Among Gram-Positive Clinical Isolates From the Worldwide SENTRY Surveillance Studies for Lefamulin

(PDF, 400KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Commonly Causing Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Bloodstream Infections (BSI): Global SENTRY Surveillance 2016

(PDF, 849KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Commonly Causing Community-Acquired Respiratory Tract Infections (CARTI) – Global SENTRY Surveillance 2016

(PDF, 4.40MB)

Tissue Distribution of [14C]-Lefamulin Into the Urogenital Tract in Rats

 

ASM MICROBE 2017

Nabriva presented four poster presentations on lefamulin’s in vitro activity against key pathogens commonly causing respiratory tract infections and ten Scientific papers on Fosfomcycin at ASM Microbe in New Orleans, LA.

(PDF, 131KB)

Fosfomycin Activity When Tested Against Gram-positive and Gram-negative US Isolates Collected by the SENTRY Antimicrobial Surveillance Program (R. K. Flamm, et al, ASM Microbe, June 3, 2017)

(PDF, 213KB)

Fosfomycin In Vitro Activity Against Bacteria with Various Mechanisms of Resistance to other Antibacterials from US Hospitals (D. Shortridge, et al, ASM Microbe, June 3, 2017)

(PDF, 482KB)

Fosfomycin (FOS) for Injection: Activity Against Carbapenem-resistant and Ceftazidime-avibactam Resistant Enterobacteriaceae (CRE) Clinical Isolates with Diverse Resistance Mechanisms (C. Clancy, et al, ASM Microbe, June 3, 2017)

(PDF, 27KB)

Population Pharmacokinetic (PK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Phase 1 Data for ZTI-01 and Evaluation of a Phase 2/3 Sparse PK Sampling Strategy (M. Trang, et al, ASM Microbe, June 3, 2017)

(PDF, 178KB)

Pharmacokinetics-Pharmacodynamics (PK-PD) Target Attainment Analyses to Support ZTI-01 (Fosfomycin for Injection) Dose Selection for Patients with Complicated Urinary Tract Infections (cUTI) (S. M. Bhavnani, et al, ASM Microbe, June 3, 2017)

(PDF, 123KB)

Pharmacokinetics, Safety, and Tolerability of Single Dose Intravenous and Oral Fosfomycin in Healthy Volunteers (E. Wenzler, et al, ASM Microbe, June 3, 2017)

(PDF, 131KB)

In Vivo Pharmacodynamics of ZTI-01 (Fosfomycin for Injection) in the Neutropenic Murine Thigh Infection Model Against ESBL-positive E. coli (EC), Carbapenem-resistant (CR) K. pneumoniae (KPN), and P. aeruginosa (PSA) (A. J. Lepak, et al, ASM Microbe, June 3, 2017)

(PDF, 68KB)

Evaluation of the Antimicrobial Activity of Fosfomycin When Combined with Selected Antimicrobial Agents and Tested Against Bacterial Isolates Using Checkerboard Methods (P. R. Rhomberg, et al, ASM Microbe, June 3, 2017)

(PDF, 131KB)

Correlation of Reference Agar Dilution MIC Values and Kirby-Bauer Disk Diffusion Testing for Fosfomycin Against Gram-positive and Gram-negative Bacteria (R. K. Flamm, et al, ASM Microbe, June 3, 2017)

(PDF, 152KB)

Time Kill Analyses of Concerning Gram-negative Bacteria (GNB) by Fosfomycin Alone and in Combination with Select Antimicrobial Agents (R. K. Flamm, et al, ASM Microbe, June 2, 2017)

(PDF, 343KB)

In Vitro Activity of Lefamulin against a Collection of Respiratory Pathogens from Pediatric Patients In US (SENTRY Surveillance 2015)

(PDF, 343KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Collected from Patients with Community-Acquired Bacterial Pneumonia (CABP) – SENTRY 2015 US Data

(PDF, 273KB)

In Vitro Antibacterial Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in US

(PDF, 273KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Pneumonia Collected from Patients in Asia (2015)

American Thoracic Society (ATS)

ATS 2022

(PDF, 515KB)

Lefamulin Efficacy and Safety in Adults With Community-Acquired Bacterial Pneumonia (CABP): Pooled Analysis of The Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials in Patients With Asthma or Chronic Obstructive Lung Disease (COPD)

CHEST

CHEST 2022

(PDF, 130KB)

LEFAMULIN EFFICACY IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) IS UNAFFECTED BY OBESITY: POOLED ANALYSIS OF THE LEFAMULIN PHASE-3 CLINICAL TRIAL PROGRAM

CHEST 2021

(PDF, 55KB)

LEFAMULIN EFFICACY AND SAFETY IN ADULTS WITH COMMUNITYACQUIRED BACTERIAL PNEUMONIA: POOLED ANALYSIS OF THE LEFAMULIN EVALUATION AGAINST PNEUMONIA (LEAP) 1 AND LEAP 2 TRIALS IN PATIENTS WITH MULTILOBAR OR UNILOBAR PNEUMONIA

CHEST 2020

(PDF, 580KB)

Lefamulin Efficacy and Safety in Adults With Community-Acquired Bacterial Pneumonia: Pooled Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Trials by Age Group, Including in Patients Aged ≥85 Years

CHEST 2019

(PDF, 543KB)

Efficacy and Safety of Lefamulin Versus Moxifloxacin for Atypical Respiratory Pathogens in Adults With Community-Acquired Bacterial Pneumonia: Pooled Results From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

(PDF, 543KB)

Efficacy of Lefamulin Versus Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

(PDF, 543KB)

Safety and Tolerability of Lefamulin Versus Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia: Results of the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Double-Blind Noninferiority Phase 3 Clinical Trials

European Congress Of Clinical Microbiology & Infectious Diseases (ECCMID)

ECCMID 2022

Nabriva presented 4 posters at ECCMID 2022 that support lefamulin’s in vitro activity against S. aureus globally and a collection of CAP pathogens across Europe, as well as lefamulin susceptibility testing methods.

(PDF, 1474KB)

Lefamulin Activity against a Contemporary Global Collection of Staphylococcus aureus (SENTRY 2020–2021)

(PDF, 1200KB)

Lefamulin Activity against Bacterial Pathogens Typically Causing Pneumonia Collected from European Medical Centers in 2020 and 2021

(PDF, 2234KB)

Evaluation of the Oxoid Lefamulin 20 μg Antimicrobial Susceptibility Testing (AST) Disc Against the Predicate Lefamulin 20 μg AST Disc

(PDF, 367KB)

Comparison of Lefamulin MIC Test Strip (MTS) to Broth Microdilution MIC for Streptococcus spp., S. aureus, M. catarrhalis, and Haemophilus spp.

ECCMID 2021

Nabriva presented one oral presentation and 2 e-posters at ECCMID 2021 that supports lefamulin’s in vitro activity regarding pathogens that commonly cause community-acquired bacterial pneumonia (EU isolates), Cystic Fibrosis (isolates from non-CF pediatric patients), and Pleuromutilin resistance mechanisms.

(PDF, 504KB)

In Vitro Activity of Lefamulin against Staphylococcus aureus and Haemophilus influenzae, Common Pathogens in Cystic Fibrosis (CF), Collected from non-CF Paediatric Patients (SENTRY Surveillance 2015-2019)

(PDF, 301KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens causing Pneumonia and Other Respiratory Tract Infections in Europe: Results from the SENTRY Surveillance Program (2019-2020)

(PDF, 1189KB)

Evaluation of Pleuromutilins Resistance Mechanisms Among Surveillance Clinical Isolates: Results from the Worldwide Surveillance Program for Lefamulin in 2019

ECCMID 2019

Nabriva presented 8 posters/e-posters at ECCMID 2019 that support lefamulin and CONTEPO as potential first-in-class antibiotics in the United States that target the most common causative pathogens of CABP and cUTI, including multi-drug resistant (MDR) strains.

(PDF, 368KB)

Oral Lefamulin Demonstrates Favorable Safety and Tolerability in Adults With Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 2) Study

(PDF, 543KB)

Microbiology and Outcomes Among Patients Hospitalised With Suspected Community-Acquired Bacterial Pneumonia (CABP): A Multi-Centre Retrospective Cohort Study

(PDF, 437KB)

Bacterial Pathogen–Positive Patients Hospitalised With Suspected Community-Acquired Bacterial Pneumonia (CABP) Have Worse Outcomes Than Those With Negative or No Culture: A Multi-Centre Retrospective Cohort Study

(PDF, 473KB)

Antimicrobial Activity of Lefamulin Against a Large Longitudinal Collection of Clinical Bacterial Isolates Collected Worldwide Results From the SENTRY Antimicrobial Surveillance Programme

(PDF, 1928KB)

In Vitro Activity of Lefamulin Against Isolates Commonly Causing Community-Acquired Bacterial Pneumonia Collected During the SENTRY Surveillance Programme 2017 in Europe

(PDF, 4243KB)

Population Pharmacokinetic Analysis for Lefamulin Using Data From Healthy Volunteers and Infected Patients

(PDF, 518KB)

Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Lefamulin Dose Justification and Susceptibility Breakpoint Determinations for Patients With Community-Acquired Bacterial Pneumonia

ECCMID 2018

Nabriva presented 8 posters/e-posters at ECCMID 2018.  Six posters were presented on lefamulin. Two from the phase 3 clinical development program, LEAP 1 IV to Oral switch study as monotherapy in adult patients with CABP, described the primary outcome measures of the first phase 3 trial as well as the safety and tolerability data. In 3 in vitro studies, presented were the bactericidal activity of lefamulin against S. pneumoniae, the activity of lefamulin and comparators against a contemporary collection of S. aureus isolates from Europe in 2016 as well as the evaluation of the activity of lefamulin and comparators against a collection of bacterial respiratory pathogens from Europe in 2016. One pre-clinical investigation of the distribution of lefamulin in tissue structures of the urogenital tract in rats was presented. Two epidemiologic investigations presented the hospital-level usage of high-risk antibiotics and associated CDI rates and epidemiology of bacteria in patients with culture-positive CABP who received empiric antibiotic therapy and were admitted to acute-care hospitals in the United States.

(PDF, 434KB)

Lefamulin Demonstrates Favorable Safety and Tolerability in Adults with Community-Acquired Bacterial Pneumonia (CABP) in the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 4963KB)

Tissue Distribution of [14C]-Lefamulin in the Urogenital Tract in Rats

(PDF, 935KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Collected From Patients With Community- or Hospital-Acquired Respiratory Tract Infections: 2016 SENTRY Data From Europe

(PDF, 450KB)

In Vitro Bactericidal Activity of Lefamulin Against Streptococcus pneumoniae Isolates

(PDF, 523KB)

Correlation of high-risk antibiotic use and hospital-associated C. difficile infections: data from 195 US hospitals

(PDF, 391KB)

A multicentre evaluation of pathogen distribution in culture positive patients admitted with pneumonia in the US

(PDF, 434KB)

In Vitro Activity of Lefamulin against Contemporary Staphylococcus aureus Isolates from Patients in Europe (SENTRY 2016)

(PDF, 478KB)

Lefamulin is Non-inferior to Moxifloxacin in Adults with Community-Acquired Bacterial Pneumonia (CABP): The Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

ECCMID 2017

Nabriva presented a total of 9 posters or oral presentations for lefamulin on Pharmacokinetics in fed and fasted healthy subjects, Population Pharmacokinetic analysis in plasma and epithelial lining fluid, Pharmacokinetic-Pharmacodynamic Target Attainment analyses to support the evaluation of intravenous and oral dosing regimens for the treatment of patients with Community-Acquired Bacterial Pneumonia (CABP), Activity against the key bacteria known to cause CABP (including multi-drug resistant strains) and STI - M. genitalium, and Mechanism of action: selectivity to inhibit bacterial protein synthesis at ECCMID in Vienna, Austria. (One podium presentation is not yet available.)

(PDF, 479KB)

Population Pharmacokinetic (PPK) Analysis for Lefamulin Plasma and Epithelial Lining Fluid (ELF) Exposures Using Data from Healthy Subjects

(PDF, 177KB)

Lefamulin Selectively Inhibits Bacterial Protein Synthesis

(PDF, 378KB)

In Vitro Activity of Lefamulin against Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP): 2015 SENTRY Data from Europe

(PDF, 242KB)

In Vitro Activity of Lefamulin against S. aureus from Hospital-Acquired Pneumonia (HAP) and Community-Acquired Pneumonia (CAP) Patients in Europe

(PDF, 256KB)

In Vitro Activity of Lefamulin against S. aureus Collected from Hospitalized Patients with Bacterial Pneumonia in Europe

(PDF, 254KB)

In Vitro Activity of Lefamulin against Global Collection of Respiratory Pathogens from Paediatric Patients from the 2015 Sentry Program

(PDF, 143KB)

Lefamulin is Highly Active In Vitro Against Multi-drug Resistant Mycoplasma genitalium Strains

(PDF, 746KB)

Pharmacokinetics and Safety of an Oral, Immediate-Release (IR) Tablet Formulation of Lefamulin in Fed and Fasted Healthy Subjects

ECCMID 2015

Nabriva presented posters on the Extended Spectrum Pleuromutilins (ESP) program at ECCMID.

(PDF, 180KB)

In Vitro and In Vivo Efficacy of Novel Extended Spectrum Pleuromutilins Against S. aureus and S. pneumoniae

(PDF, 508KB)

Kill Curves of the Novel Extended-Spectrum Pleuromutilin Antibiotic BC-9529

(PDF, 138KB)

Efficacy of Novel Extended Spectrum Pleuromutilins Against E. coli In Vitroand In Vivo

ECCMID 2014

Nabriva presented four posters on the Extended Spectrum Pleuromutilins (ESP) program at ECCMID.

(PDF, 60KB)

AntibacteriaL In Vitro Activity of Novel Extended Spectrum Pleuromutilins Against Gram-Positive and -Negative Bacterial Pathogens

(PDF, 100KB)

Extended Spectrum Pleuromutilins: Mode-of-Action Studies

(PDF, 50KB)

In Vitro Metabolism and In Vivo Pharmacokinetics of Novel Extended Spectrum Pleuromutilin Antibiotics

(PDF, 50KB)

In Vivo Activity of Extended Spectrum Pleuromutilins in Murine Sepsis Model

ECCMID 2011

Nabriva presented data suggesting no major CYP450-mediated drug-drug interactions are expected with BC-3781.

(PDF, 200KB)

BC-3781: Evaluation of the CYP3A Interaction Potential

ECCMID 2010

Nabriva presented in vitro and in vivo efficacy data of pleuromutilin antibacterials BC-3205 and BC-3781 supporting further development in ABSSSI and CABP indications. Phase 1 data demonstrated safety and tolerability of the intravenous BC-3781 formulation.

(PDF, 100KB)

Safety, Tolerance and Pharmacokinetics of Single and Repeat Doses of BC-3781, a Novel Antimicrobial

(PDF, 100KB)

In Vivo Pharmacodynamic Activity of BC-3781

(PDF, 300KB)

Pharmacokinetic, Mass Balance and Tissue Distribution of [14C]-BC-3781 in Non-pigmented Rats

(PDF, 100KB)

Antimicrobial Activity of the Investigational Pleuromutilin Compound BC-3781 Against Gram-positive Organisms Commonly Associated with Cutaneous Infections

(PDF, 300KB)

Correlation of In Vitro Susceptibility Testing Results for an Investigational Pleuromutilin (BC-3781) Using MIC and Disk Diffusion Methods Against Gram-Positive Pathogens

(PDF, 300KB)

Pharmacokinetic, Mass Balance and Tissue Distribution of [14C]-BC-3205 in Non-pigmented Rats

(PDF, 150KB)

Activity of BC-3205 When Tested against a Collection of Gram-Positive Organisms Responsible for Skin and Skin Structure Infections

(PDF, 200KB)

Correlations of Broth Microdilution MIC and Disk Diffusion Results for an Investigational Agent, BC-3205 Among Potentially Indicated Species

IDWEEK

IDWeek 2022

Nabriva presented poster presentations on lefamulin at IDWeek.

(PDF, 501KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Collected From Pneumonia Patients in United States and Latin America Medical Centers in 2020-2021

(PDF, 463KB)

Anti-Inflammatory Activity of Lefamulin in a Mouse Model of Influenza Virus H1N1 Infection

IDWeek 2021

Nabriva presented a poster presentation on lefamulin a at IDWeek.

(PDF, 1,279KB)

In Vitro Activity of Lefamulin against Staphylococcus aureus Isolated from the Lower Respiratory Tract of Children with Cystic Fibrosis

IDWeek 2019

Nabriva presented three poster presentations on Fosfomycin and eleven poster presentations on lefamulin at IDWeek in Washington, DC.

(PDF, 463KB)

Efficacy of Fosfomycin for Injection vs Piperacillin-Tazobactam in Adults With Complicated Urinary Tract Infection and Acute Pyelonephritis: ZEUS Study Outcomes in Patients With Reduced Study Drug Susceptibility or Clinical Relapse at Late Follow-Up

(PDF, 1018KB)

Prevalence and Regional Variation in ESBLs and CRE Enterobacteriaceae (ENT) Among Hospitalized Adult Patients with ENT on a Urine Culture: A Multicenter Evaluation

(PDF, 656KB)

Trends in Important Resistant Gram-negative (GN) and Gram-positive (GP) Urine Bacterial Pathogens in Hospitalized Patients in the US: A Multicenter Evaluation from 2013-2018

(PDF, 439KB)

Pharmacokinetics and Safety of Lefamulin After Single Intravenous Dose Administration in Subjects With Impaired Renal Function and in Those Requiring Hemodialysis

(PDF, 472KB)

Pharmacokinetics and Safety of Lefamulin After Single Intravenous Dose Administration in Subjects With Impaired Hepatic Function

(PDF, 1856KB)

In Vitro Activity of Lefamulin Against Bacterial Pathogens Causing Community-Acquired Bacterial Pneumonia: SENTRY Surveillance 2017–2018 Results From the United States

(PDF, 452KB)

Cardiac Safety in Adults With Community-Acquired Bacterial Pneumonia Treated With Lefamulin or Moxifloxacin: Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results

(PDF, 461KB)

Hepatobiliary Safety in Adults With Community-Acquired Bacterial Pneumonia Treated With Lefamulin or Moxifloxacin: Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Result

(PDF, 558KB)

Efficacy and Symptom Resolution by Visit in Adults With Community-Acquired Bacterial Pneumonia Treated With Lefamulin or Moxifloxacin: Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results

(PDF, 724KB)

Efficacy and Safety of Lefamulin Versus Moxifloxacin for Legionella pneumophila in Patients With Community-Acquired Bacterial Pneumonia: Pooled Results From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 Clinical Trials

(PDF, 545KB)

Oral 5-Day Lefamulin for Outpatient Management of Pneumonia Outcomes Research Team Risk Class III/IV Community-Acquired Bacterial Pneumonia: Post Hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Phase 3 Study

(PDF, 502KB)

Lefamulin Versus Moxifloxacin in Patients With Community-Acquired Bacterial Pneumonia at Risk for Poor Efficacy or Safety Outcomes: Pooled Subgroup Analyses From the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Phase 3 Noninferiority Clinical Trials

(PDF, 415KB)

Health-Related Quality of Life as Measured by the 12-Item Medical Outcomes Study Short-Form Among Adults With Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxacin in Two Phase 3 Randomized, Double-Blind, Double-Dummy Clinical Trials (LEAP 1 and 2)

(PDF, 690KB)

Efficacy in Adults With Moderate to Severe Community-Acquired Bacterial Pneumonia and Pneumonia Outcomes Research Team Risk Class III to V: Results of a Pooled Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Outcomes

IDWeek 2018

Nabriva presented three poster presentations on lefamulin and eight scientific papers on Fosfomycin at IDWeek in San Diego, CA.

(PDF, 477KB)

Clinical Cure in Secondary Efficacy Populations in Patients With Complicated Urinary Tract Infection Treated With ZTI-01 (Fosfomycin for Injection): Findings From the ZEUS Trial

(PDF, 510KB)

Efficacy of Lefamulin Versus Moxifloxacin Against Common Pathogens in Adults With Community-Acquired Bacterial Pneumonia (CABP): Results From the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 1MB)

In Vitro Activity of Lefamulin (LEF) Against Bacterial Pathogens Causing Community-Acquired Bacterial Pneumonia (CABP):SENTRY Surveillance 2016 Results From Asia-Pacific (APAC) and Latin America (LA)

(PDF, 1.6MB)

In Vitro Activity of Lefamulin (LEF) Against Bacterial Pathogens Commonly Causing Community‑Acquired Bacterial Pneumonia (CABP): 2016 SENTRY Data From the United States

IDWeek 2017

Nabriva presented three poster presentations on lefamulin and eight scientific papers on Fosfomycin at IDWeek in San Diego, CA.

(PDF, 148KB)

Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI) (Michael Trang, Pharm.D., et al, ID Week, October 7, 2017)

(PDF, 149KB)

Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS) (Paul B Eckburg, MD, et al, ID Week, October 7, 2017)

(PDF, 482KB)

Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) who Received Intravenous Fosfomycin (ZTI-01) (Paul B Eckburg, MD, et al, ID Week, October 7, 2017)

(PDF, 257KB)

Phenotypic Antibiotic Resistance in ZEUS: A Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) (Evelyn J. Ellis-Grosse, Ph.D., et al, ID Week, October 7, 2017)

(PDF, 18KB)

In vitro Activity of Fosfomycin, Alone and Combined with Cefepime and Meropenem, Against Carbapenemase-Producing Gram-Negative Bacteria (Nathan P. Wiederhold, PharmD, et al, ID Week, October 6, 2017)

(PDF, 113KB)

ZTI-01 Treatment Improves Survival of Animals Infected with Multidrug Resistant Pseudomonas aeruginosa (Evelyn J. Ellis-Grosse, Ph.D., et al, ID Week, October 6, 2017

(PDF, 113KB)

Fosfomycin (FOS) Plus Meropenem (MER) Suppresses Resistance Emergence Against P. aeruginosa (PA) PAO1 in the Hollow Fiber Infection Model (HFIM) (Arnold Louie, M.D., et al, ID Week, October 6, 2017)

(PDF, 20KB)

Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP) (David Skarinsky, BS, et al, ID Week, October 7, 2017)

(PDF, 351KB)

In Vitro Activity of Lefamulin against S. aureus Collected Worldwide from Hospitalized Patients with Bacterial Pneumonia

(PDF, 377KB)

In Vitro Activity of Lefamulin against a Global Collection of Bacterial Pathogens Commonly Causing Community-Acquired Bacterial Pneumonia (CABP) – SENTRY 2015

(PDF, 301KB)

Efficacy of Lefamulin against Staphylococcus aureus-induced Bacterermia in a Neutropenic and Immunocompetent Murine Model

IDWeek 2016

Nabriva presented posters on Population Pharmacokinetic Analysis for Lefamulin and Pharmacokinetic-Pharmacodynamic Target Attainment Analyses to Support Oral Lefamulin Dose Selection in the Treatment of Patients with Community-Acquired Bacterial Pneumonia at the IDWeek conference in New Orleans, LA.

(PDF, 598KB)

Population Pharmacokinetic-Pharmacodynamic Target Attainment to Support Oral Lefamulin Dose Selection in the Treatment of Patients with Community-Acquired Bacterial Pneumonia

(PDF, 249KB)

Population Pharmacokinetic Analysis for Lefamulin Using Phase 1 Data and Assessment of Optimal PK Sampling Strategies for a Phase 3 Community-Acquired Bacterial Pneumonia Study

IDWeek 2015

Nabriva presented one poster on Lefamulin target attainment at the 2015 Infectious Diseases Week conference (San Diego, CA).

(PDF, 410KB)

Pharmacokinetic-Pharmacodynamic (PK-PD) Target Attainment (TA) Analyses Supporting Lefamulin Dose Selection for the Treatment of Patients with Community-Acquired Bacterial Pneumonia (CABP)

ISPOR

ISPOR 2019

Nabriva presented two poster presentations on lefamulin at ISPOR in New Orleans, LA

(PDF, 1,015KB)

One-year Economic Burden Among Patients with Community-Acquired Pneumonia (CAP) Initially Managed in the Outpatient Setting: A Retrospective US Cohort Study, 2012-2017

(PDF, 430KB)

Economic Outcomes of Patients with Community-Acquired Pneumonia (CAP) Hospitalizations in the US: A Retrospective Cohort Study, 2012–2017

MAD-ID

MAD-ID 2019

Nabriva presented three poster presentations on lefamulin at MAD-ID in Orlando, FL

(PDF, 270KB)

Lefamulin Is Noninferior to Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia: Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study

(PDF, 200KB)

Post Hoc Assessment of Time to Clinical Response (TTCR) Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin (LEF) or Moxifloxacin (MOX) in Two Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials

(PDF, 130KB)

Oral Lefamulin Is Safe and Effective in the Treatment of Adults With Community-Acquired Bacterial Pneumonia (CABP): Results of Lefamulin Evaluation Against Pneumonia (LEAP 2) Study

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Health-related quality of life as measured by the 12-item short-form survey among adults with community-acquired bacterial pneumonia who received either lefamulin or moxifloxacin in two phase III randomized, double-blind, double-dummy clinical trials

Lodise T, Colman S, Alexander E, et al.

Open Forum Infect Dis. 2020;7(6):ofaa209.

The 1-year economic burden of community-acquired pneumonia (CAP) initially managed in the outpatient setting in the US

Divino V, Schranz J, Early M, Shah H, Jiang M, DeKoven M

J Comp Eff Res. 2020;9(2):127-140.

Health-related quality of life as measured by the 12-item short-form survey among adults with community-acquired bacterial pneumonia who received either lefamulin or moxifloxacin in two phase III randomized, double-blind, double-dummy clinical trials

Lodise T, Colman S, Alexander E, et al.

Open Forum Infect Dis. 2020;7(6):ofaa209.

The annual economic burden among patients hospitalized for community-acquired pneumonia (CAP): a retrospective US cohort study

Divino V, Schranz J, Early M, Shah H, Jiang M, DeKoven M

Curr Med Res Opin. 2020;36(1):151-160.

Hospital-level high-risk antibiotic use in relation to hospital associated Clostridioides difficile infections: retrospective analysis of 2016-2017 data from US hospitals

Tabak YP, Srinivasan A, Yu KC, et al.

Infect Control Hosp Epidemiol. 2019;40(11):1229-1235.

Pharmacokinetic-pharmacodynamic target attainment analyses to support intravenous and oral lefamulin dose selection for the treatment of patients with community-acquired bacterial pneumonia

Bhavnani SM, Zhang L, Hammel JP, et al.

J Antimicrob Chemother. 2019;74(Suppl 3):iii35–iii41.

Prediction of lefamulin epithelial lining fluid penetration after intravenous and oral administration using phase 1 data and population pharmacokinetics methods

Zhang L, Wicha WW, Bhavnani SM, Rubino CM

J Antimicrob Chemother. 2019;74(Suppl 3):iii27–iii34.

Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing

Wicha WW, Prince WT, Lell C, Heilmayer W, Gelone SP

J Antimicrob Chemother. 2019;74(Suppl 3):iii19–iii26.

Pharmacokinetics/pharmacodynamics of lefamulin in a neutropenic murine pneumonia model with Staphylococcus aureus and Streptococcus pneumoniae

Wicha WW, Strickmann DB, Paukner S

J Antimicrob Chemother. 2019;74(Suppl 3):iii11–iii18.

In vivo pharmacodynamics of lefamulin, the first systematic pleuromutilin for human use, in a neutropenic murine thigh infection model

Wicha WW, Craig WA, Andes D

J Antimicrob Chemother. 2019;74(Suppl 3):iii5–iii10.

Introduction: lefamulin and pharmacokinetic-pharmacodynamic rationale to support the dose selection of lefamulin

Rodvold KA

J Antimicrob Chemother. 2019;74(Suppl 3):iii2–iii4.

Antibacterial activity of lefamulin against pathogens most commonly causing community-acquired bacterial pneumonia: SENTRY antimicrobial surveillance program (2015–2016)

Paukner S, Gelone SP, Arends SJR, Flamm RK, Sader HS

Antimicrob Agents Chemother. 2019;63(4):e02161-18.

Low prevalence of Gram-positive isolates showing elevated lefamulin MIC Results during the SENTRY surveillance program for 2015–2016 and characterization of resistance mechanisms

Mendes RE, Paukner S, Doyle TB, Gelone SP, Flamm RK, Sader HS

Antimicrob Agents Chemother. 2019;63(4):e02158-18.

Reply to Tang and Lai

File TM Jr, Gelone SP, Schranz J, Alexander E

Clin Infect Dis. doi: https://doi.org/10.1093/cid/ciz1174.

In vitro activity of lefamulin against sexually transmitted bacterial pathogens

Paukner S, Gruss A, Jensen JS

Open Forum Infect Dis. 2020;7(6):ofaa209.

Health-related quality of life as measured by the 12-item short-form survey among adults with community-acquired bacterial pneumonia who received either lefamulin or moxifloxacin in two phase III randomized, double-blind, double-dummy clinical trials

Lodise T, Colman S, Alexander E, et al.

Antimicrob Agents Chemother. 2018;62(5):e02380-17.

A multicenter evaluation of the US prevalence and regional variation in macrolide-resistant S. pneumoniae in ambulatory and hospitalized adult patients in the US

Gupta V, Yu KC, Schranz J, Jokinen-Gordon H, Gelone SP

Open Forum Infectious Diseases, 2021;, ofab063,  https://doi.org/10.1093/ofid/ofab063

Oral 5-day lefamulin for outpatient management of community-acquired bacterial pneumonia: post hoc analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 trial

LoVecchio F, Schranz J, Alexander E, et al.

J Emerg Med. doi: https://doi.org/10.1016/ j.jemermed.2021.02.001.

Post Hoc Assessment of Time to Clinical Response Among Adults Hospitalized with Community-Acquired Bacterial Pneumonia Who Received Either Lefamulin or Moxifloxacin in Two Phase III Randomized, Double- Blind, Double-Dummy Clinical Trials

Lodise T, Coleman S, Stein D, et al.

Open Forum Infectious Diseases, , ofaa145, https://doi.org/10.1093/ofid/ofaa145; published online April 24, 2020

Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial

File TM Jr, Goldberg L, Das A, Sweeney C, et al.

Clinical Infectious Diseases, Volume 69, Issue 11, 1 December 2019, Pages 1856–1867, https://doi.org/10.1093/cid/ciz090

Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia

Elizabeth Alexander, MD, MSc, Lisa Goldberg, MS, Anita F. Das, PhD, et al.

JAMA. Published online September 27, 2019. doi:10.1001/jama.2019.15468

In vitro activity of the novel pleuromutilin lefamulin (BC-3781) and effect of efflux pump inactivation on multidrug-resistant and extensively-drug resistant Neisseria gonorrheae

Jacobbson S, Paukner S, Golparian D, et al.

Antimicrob Agents Chemother 2017 Sept 11. pii: AAC.01496-17. doi: 10.1128/AAC.01497-17. [Epub ahead of print]

Pleuromutilins: Potent drugs for resistant bugs – mode of action and resistance

Paukner S, Riedl R

Cold Spring Harb Perspect Med 2017 Jan 3; 7(1): pii: a027110. doi: a027110.

In vitro activities of lefamulin and other antimicrobial agents against macrolide-susceptible and macrolide-resistant Mycoplasma pneumoniae from the United States, Europe, and China

Waites KB, Crabb DM, Duffy LB, et al.

Antimicrob Agents Chemother 2017 Feb; 61(2): pii: e02008-16.doi: 10.1128/AAC.02008-16.

In Vitro Activity of Lefamulin Tested against Streptococcus pneumoniae with Defined Serotypes, Including Multidrug-Resistant Isolates Causing Lower Respiratory Tract Infections in the United States.

Mendes RE, Farrell DJ, Flamm RK, et al.

Antimicrob Agents Chemother 2016 Jun 20; 60(7): 4407-11.

Simultaneous assessment of the pharmacokinetics of a pleuromutilin, lefamulin, in plasma, soft tissues and pulmonary epithelial lining fluid

Zeitlinger M, Schwameis R, Burian A, et al.

J Antimicrob Chemother 2016 Apr; 71(4): 1022-6.

Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections

Rubino CM, Xue B, Bhavnani SM, et al.

Antimicrob Agents Chemother 2015 Jan; 59(1): 282-8.

Structural insights into species-specific features of the ribosome from the pathogen Staphylococcus aureus

Eyala Z, Matzova D, Krupkina M, et al.

Proc Natl Acad Sci U S A. 2015 Oct 27; 112(43): E5805–E5814.

Antimicrobial activity of the pleuromutilin antibiotic BC-3781 against bacterial pathogens isolated in the SENTRY antimicrobial surveillance program in 2010

Paukner S, Sader HS, Ivezic-Schoenfeld Z, Jones RN

Antimicrob Agents Chemother 2013 Sept; 57(9): 4489-95.

Phase II clinical study of BC-3781, a pleuromutilin antibiotic, in treatment of patients with acute bacterial skin and skin structure infections

Prince WT, Ivezic-Schoenfeld Z, Lell C, et al.

Antimicrob Agents Chemother 2013 May; 57(5): 2087-94.

Antimicrobial activity of the novel pleuromutilin antibiotic BC-3781 against organisms responsible for community-Acquired respiratory tract infections (CARTIs)

Sader HS, Paukner S, Ivezic-Schoenfeld Z., et al.

J Antimicrob Chemother 2012 May; 67(5): 1170-5.

Antimicrobial activity of the investigational pleuromutilin compound BC-3781 tested against Gram-positive organisms commonly associated with acute bacterial skin and skin structure Infections

Sader HS, Biedenbach DJ, Paukner S, et al.

Antimicrob Agents Chemother 2012 Mar; 56(3): 1619-23.

Disk diffusion and MIC quality control ranges for BC-3205 and BC-3781, two novel pleuromutilin antibiotics

Ross JE, Sader HS, Ivezic-Schoenfeld Z, et al.

J Clin Microbiol 2012 Oct; 50(10): 3361-4.

Are pleuromutilin antibiotics finally fit for human use?

Novak R

Ann N Y Acad Sci 2011 Dec; 1241: 71-81.

The pleuromutilin antibiotics: A new class for human use

Novak R, Shales DM

Curr Opin Investig Drugs 2010 Feb; 11(2): 182-91.

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