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AB-DiRecT SIGNED

Antibiotic Distribution and Recovery in Tissue

Total Cost €

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EC-Contrib. €

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Partnership

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 AB-DiRecT project word cloud

Explore the words cloud of the AB-DiRecT project. It provides you a very rough idea of what is the project "AB-DiRecT" about.

determined    elective    trials    negative    infection    determinants    oral    classes    antibacterials    gsk    imposes    infections    efficacy    antimicrobials    isolates    poppk    infected    health    pkpd    understand    vitro    gepotidacin    economic    conduct    dose    provision    surgery    difference    antimicrobial    first    animal    pathogens    action    requiring    burden    agents    discovery    tonsillectomy    resistance    single    selective    ab    coli    models    urgent    treat    treatment    prostatectomy    uncomplicated    tissue    healthcare    class    antibacterial    gonorrhoea    active    gram    regimens    positive    data    mechanism    penetration    acute    prostate    levels    broad    resistant    pharyngeal    urinary    exposure    pk    pbpk    explore    tract    tonsil    direct    clinical    body    explored    plasma    antibiotics    threat    fluoroquinolones    microdialysis    caused    sites    contemporary    undergoing    gonorrhoeae    subjects    model    triazaacenaphthylene    healthy    urogenital    prostatitis   

Project "AB-DiRecT" data sheet

The following table provides information about the project.

Coordinator
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE 

Organization address
address: RUE DE TOLBIAC 101
city: PARIS
postcode: 75654
website: www.inserm.fr

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Total cost 3˙789˙717 €
 EC max contribution 3˙429˙217 € (90%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2018-16-single-stage
 Funding Scheme IMI2-RIA
 Starting year 2019
 Duration (year-month-day) from 2019-07-01   to  2021-06-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE FR (PARIS) coordinator 1˙234˙278.00
2    MEDIZINISCHE UNIVERSITAET WIEN AT (WIEN) participant 1˙116˙375.00
3    CENTRE HOSPITALIER UNIVERSITAIRE DE POITIERS FR (POITIERS CEDEX) participant 539˙188.00
4    INSERM - TRANSFERT SA FR (PARIS) participant 335˙625.00
5    CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS FR (TOURS CEDEX 9) participant 203˙750.00
6    GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD. UK (BRENTFORD) participant 0.00

Map

 Project objective

Antimicrobial resistance imposes an important health and economic burden with the threat of a future without effective antibiotics requiring major changes to contemporary healthcare provision. Therefore, the discovery and development of novel mechanism of action agents able to treat resistant infections is a key urgent need. Gepotidacin is a first in class, novel triazaacenaphthylene antibacterial that is being developed by GSK. Due to its novel mechanism of action, gepotidacin is active in vitro against most target pathogens carrying resistance determinants to established antibacterials, including fluoroquinolones. Gepotidacin has broad gram-positive activity and selective gram-negative activity and is currently under development as a treatment for infections caused by N. gonorrhoeae (urogenital gonorrhoea) and E. coli (acute uncomplicated urinary tract infections), including isolates resistant to existing classes of antimicrobials. To explore the potential of gepotidacin to treat infections caused by N. gonorrhoeae or E. coli at other body sites, the AB-DiRecT consortium will conduct a tissue distribution study in tonsil and prostate after single oral dose of gepotidacin in healthy (non-infected) subjects undergoing elective tonsillectomy or prostatectomy. Microdialysis will be used to measure gepotidacin levels in tissue following surgery and PBPK, PopPK and PKPD models will be built to understand the tissue penetration of gepotidacin to characterize exposure response and to evaluate different dose regimens. Difference between infected and healthy tissue will be explored in an animal prostatitis infection model where gepotidacin PK in plasma and tissue will be determined using microdialysis. Overall the data generated in AB-DiRecT may support the potential for clinical trials to determine the efficacy of gepotidacin for the treatment for pharyngeal N. gonorrhoeae infections and / or prostatitis caused by E. coli.

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