Cargando…

Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study

INTRODUCTION: Gonorrhea, caused by Neisseria gonorrhoeae (NG), is the second most common bacterial sexually transmitted infection (STI). Rates of antimicrobial resistance to standard care are increasing worldwide, with many antibiotic classes now ineffective against NG. Gepotidacin is a first-in-cla...

Descripción completa

Detalles Bibliográficos
Autores principales:	Perry, Caroline R., Scangarella-Oman, Nicole E., Millns, Helen, Flight, William, Gatsi, Sally, Jakielaszek, Charles, Janmohamed, Salim, Lewis, David A.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer Healthcare 2023
Materias:	Study Protocol
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10581980/ https://www.ncbi.nlm.nih.gov/pubmed/37751016 http://dx.doi.org/10.1007/s40121-023-00862-6

Ejemplares similares

2832. Gepotidacin Efficacy in E. coli Drug-Resistant Phenotypes: A Pooled Analysis of the EAGLE-2 and EAGLE-3 Randomized Controlled Trials in Uncomplicated Urinary Tract Infection
por: Hooton, Thomas M, et al.
Publicado: (2023)

2837. Impact of Regulatory Guidelines on Therapeutic, Clinical, and Microbiological Success Rates in Uncomplicated Urinary Tract Infection: Results from a Two Phase 3 Randomized Controlled Trials of Oral Gepotidacin (EAGLE-2 and EAGLE-3)
por: Wagenlehner, Florian, et al.
Publicado: (2023)

P31 Efficacy and safety of oral gepotidacin in the treatment of uncomplicated urinary tract infection: results of two randomized, multicentre Phase 3 trials (EAGLE-2 and EAGLE-3)
por: Wagenlehner, Florian, et al.
Publicado: (2023)

2831. Efficacy and Safety of Gepotidacin for Uncomplicated Urinary Tract Infection: Pooled Subgroup Analyses of the EAGLE-2 and EAGLE-3 Randomized Phase 3 Trials
por: Hooton, Thomas M, et al.
Publicado: (2023)

Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation
por: Taylor, Stephanie N, et al.
Publicado: (2018)

Design of Two Phase III, Randomized, Multicenter Studies Comparing Gepotidacin with Nitrofurantoin for the Treatment of Uncomplicated Urinary Tract Infection in Female Participants
por: Perry, Caroline, et al.
Publicado: (2022)

Dose selection for a phase III study evaluating gepotidacin (GSK2140944) in the treatment of uncomplicated urogenital gonorrhoea
por: Scangarella-Oman, Nicole E, et al.
Publicado: (2023)

Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae
por: Scangarella-Oman, Nicole E., et al.
Publicado: (2018)

Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections
por: Scangarella-Oman, Nicole E., et al.
Publicado: (2022)

1482. Microbiological Analysis from a Phase II Study Evaluating Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections
por: Scangarella-Oman, Nicole, et al.
Publicado: (2019)

Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis)
por: Overcash, J. Scott, et al.
Publicado: (2020)

1479. Clinical Efficacy and Safety Analysis Evaluating Oral Gepotidacin (GSK2140944) from a Phase IIa Study in the Treatment of Uncomplicated Urinary Tract Infections
por: Overcash, J Scott, et al.
Publicado: (2019)

1480. Plasma and Urine Pharmacokinetic Analysis of Gepotidacin (GSK2140944) Following BID Oral Dosing in a Phase IIa Study for Treatment of Uncomplicated Urinary Tract Infections
por: Zimmerman, Eric I, et al.
Publicado: (2019)

1281. Longitudinal and Spatial Variation in the Human Microbiome in a Phase 2a Clinical Study of Gepotidacin in Adult Females with Uncomplicated Urinary Tract Infection
por: Nuzzo, Andrea, et al.
Publicado: (2020)

Microbiome recovery in adult females with uncomplicated urinary tract infections in a randomised phase 2A trial of the novel antibiotic gepotidacin (GSK140944)
por: Nuzzo, Andrea, et al.
Publicado: (2021)

Correction to: Microbiome recovery in adult females with uncomplicated urinary tract infections in a randomised phase 2A trial of the novel antibiotic gepotidacin (GSK2140944)
por: Nuzzo, Andrea, et al.
Publicado: (2021)

724. The In Vitro Activity of Gepotidacin and Comparator Agents Against Anaerobic Bacterial Isolates
por: Hackel, Meredith, et al.
Publicado: (2019)

In Vitro Activity of Gepotidacin against Gram-Negative and Gram-Positive Anaerobes
por: Hackel, Meredith A., et al.
Publicado: (2022)

Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
por: O'Riordan, William, et al.
Publicado: (2017)

In vitro activity of the first-in-class triazaacenaphthylene gepotidacin alone and in combination with doxycycline against drug-resistant and -susceptible Mycoplasma genitalium
por: Jensen, Jørgen Skov, et al.
Publicado: (2020)

714. Analysis of the Effect of Urine on the In Vitro Activity of Gepotidacin and Levofloxacin Against Escherichia coli, Staphylococcus epidermidis, and Staphylococcus saprophyticus
por: Koeth, Laura M, et al.
Publicado: (2019)

701. Comparison of MIC Results for Gepotidacin by Agar Dilution and Broth Microdilution Methods
por: Arends, S J Ryan, et al.
Publicado: (2019)

1262. Antimicrobial Activity of Gepotidacin against Clinical Isolates of Escherichia coli and Staphylococcus saprophyticus Collected Worldwide in 2019
por: Arends, S J Ryan, et al.
Publicado: (2020)

1249. Genetic Evidence That Gepotidacin Shows Well-balanced Dual Targeting against DNA Gyrase And Topoisomerase IV in Neisseria gonorrhoeae
por: Chan, Pan, et al.
Publicado: (2020)

Antimicrobial Activity of Gepotidacin Tested against Escherichia coli and Staphylococcus saprophyticus Isolates Causing Urinary Tract Infections in Medical Centers Worldwide (2019 to 2020)
por: Arends, S. J. Ryan, et al.
Publicado: (2023)

Gepotidacin Pharmacokinetics-Pharmacodynamics against Escherichia coli in the One-Compartment and Hollow-Fiber In Vitro Infection Model Systems
por: VanScoy, Brian D., et al.
Publicado: (2021)

Epidemiological Overview of Urogenital Gonorrhea in Mexico (2003–2020)
por: Loyola-Cruz, Miguel Ángel, et al.
Publicado: (2023)

Relationship between Gepotidacin Exposure and Prevention of On-Therapy Resistance Amplification in a Neisseria gonorrhoeae Hollow-Fiber In Vitro Infection Model
por: VanScoy, Brian D., et al.
Publicado: (2020)

Oropharyngeal Gonorrhea in Absence of Urogenital Gonorrhea in Sexual Network of Male and Female Participants, Australia, 2018
por: Cornelisse, Vincent J., et al.
Publicado: (2019)

1358. A Real-World Study of the Burden of Illness and Treatment Patterns Among Patients with Uncomplicated Urogenital Gonorrhea in the United States
por: Preib, Madison T, et al.
Publicado: (2021)

1075. In vitro Activity of Gepotidacin against Escherichia coli Causing Urinary Tract Infections in the United States, Including Molecularly Characterized Fluoroquinolone Resistant Subsets
por: Mendes, Rodrigo E, et al.
Publicado: (2021)

In Vitro Activity and Microbiological Efficacy of Gepotidacin from a Phase 2, Randomized, Multicenter, Dose-Ranging Study in Patients with Acute Bacterial Skin and Skin Structure Infections
por: Scangarella-Oman, Nicole E., et al.
Publicado: (2020)

Efficacy of Intravenously Administered Gepotidacin in Cynomolgus Macaques following a Francisella tularensis Inhalational Challenge
por: Jakielaszek, Charles, et al.
Publicado: (2023)

Systematic Review and Meta-Analysis to Estimate the Treatment Effect and Inform a Noninferiority Margin for a Phase 3 Noninferiority Trial in Uncomplicated Urogenital Gonorrhea
por: Mitrani-Gold, Fanny S., et al.
Publicado: (2022)

Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats
por: Fishman, Cindy, et al.
Publicado: (2022)

731. Pharmacokinetics of Gepotidacin (GSK2140944) in Subjects with Hepatic Impairment
por: Hands, Jonathan T, et al.
Publicado: (2019)

Pharmacokinetics of Gepotidacin in Renal Impairment
por: Hossain, Mohammad, et al.
Publicado: (2020)

Grepafloxacin Versus Cefixime as Single-Dose Therapy for Uncomplicated Gonorrhea in Women
por: Mroczkowski, T. F., et al.
Publicado: (1997)

Screening for chlamydia and/or gonorrhea in primary health care: protocol for systematic review
por: Pillay, Jennifer, et al.
Publicado: (2018)

Pharmacokinetic, Safety, and Tolerability Evaluations of Gepotidacin (GSK2140944) in Healthy Japanese Participants
por: Barth, Aline, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_d75n17rikq97t3m3v2t1v43d7p