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DRTB-HDT SIGNED

STRATIFIED HOST-DIRECTED THERAPY FOR DRUG-RESISTANT TUBERCULOSIS: A RANDOMIZED CONTROLLED MULTI-CENTRE TRIAL

Total Cost €

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EC-Contrib. €

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Partnership

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 DRTB-HDT project word cloud

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

global    54    adhere    africa    urgent    adjunctive    impairment    prevent    majority    scan    romania    11050    drug    disability    capacity    patients    tolerated    co    arms    function    public    outcomes    worldwide    germany    inflammation    enrolled    leave    risk    data    treatments    reducing    examine    complementary    randomized    cured    reduce    south    fibrosis    hdts    rif    candidates    moldova    mozambique    baseline    time    microbial    inducing    georgia    rifampicin    therapy    began    spirometry    sub    measured    poor    outcome    2016    bronchiectasis    guidelines    experimental    efficacy    endpoints    clinically    multidrug    primary    closely    permanent    lung    infection    clinical    trial    cc    mortality    culture    ground    330    sites    anti    metformin    inadequate    therapies    stable    requiring    cell    armed    conversion    hdt    strategies    treatment    shortcomings    respectively    tuberculosis    quantitative    estimates    sputum    radiographic    ct    morbidity    centre    directed    standard    poorly    magnified    vs    successful    host    health    life    breaking    receive    tb    either    regimens    resistant    national    radiodensity    preclinical    cure   

Project "DRTB-HDT" data sheet

The following table provides information about the project.

Coordinator
SCHWEIZERISCHES TROPEN- UND PUBLIC HEALTH-INSTITUT 

Organization address
address: SOCINSTRASSE 57
city: Basel
postcode: CH-4002
website: www.swisstph.ch

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 Switzerland [CH]
 Total cost 9˙969˙012 €
 EC max contribution 9˙969˙012 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2019-Two-Stage-RTD
 Funding Scheme RIA
 Starting year 2020
 Duration (year-month-day) from 2020-01-01   to  2023-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    SCHWEIZERISCHES TROPEN- UND PUBLIC HEALTH-INSTITUT CH (Basel) coordinator 1˙155˙060.00
2    THE AURUM INSTITUTE NPC ZA (PARKTOWN JOHANNESBURG) participant 3˙200˙656.00
3    WITS HEALTH CONSORTIUM (PTY) LTD ZA (Johannesburg) participant 1˙752˙440.00
4    Instituto Nacional de Saúde MZ (Maputo) participant 868˙332.00
5    LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN DE (MUENCHEN) participant 808˙922.00
6    FORSCHUNGSZENTRUM BORSTEL DE (BORSTEL) participant 753˙750.00
7    NATIONAL CENTER FOR TUBERCULOSIS AND LUNG DISEASES JSC GE (TBILISI) participant 618˙000.00
8    INSTITUTUL DE PNEUMOFTIZIOLOGIE MARIUS NASTA RO (BUCURESTI) participant 353˙750.00
9    UNIVERSITEIT ANTWERPEN BE (ANTWERPEN) participant 275˙199.00
10    "INSTITUTIA MEDICO-SANITARA PUBLICA - INSTITUTUL DE FTIZIOPNEUMOLOGIE ""CHIRIL DRAGANIUC""" MD (CHISINAU) participant 182˙901.00

Map

 Project objective

Tuberculosis is a leading cause of morbidity and mortality worldwide. Current TB treatments are inadequate, requiring patients closely adhere to multi-drug regimens that are long, complex, and often poorly tolerated. These concerns are greatly magnified in rifampicin-resistant (RIF-R) TB, an urgent global and EU public health priority. WHO estimates that only 54% of patients who began RIF-R TB treatment in 2016 were cured. In addition to these well-recognized shortcomings, current TB treatments, particularly those for RIF-R TB, leave a majority of cured patients with permanent, clinically significant lung impairment and radiographic evidence of bronchiectasis and fibrosis. This project will determine if two adjunctive host-directed therapies (HDTs) can prevent these poor outcomes. 330 patients with RIF-R TB and baseline risk factors for poor outcome will be enrolled in a randomized, controlled, 3-armed multi-centre trial, with clinical sites in Germany, Romania, Moldova, Georgia, Mozambique, and South Africa. All patients will receive standard multidrug therapy according to national guidelines. Those patients randomized to the experimental arms will in addition receive either CC-11050 or metformin. These selected HDT candidates represent 2 complementary HDT strategies: reducing inflammation vs inducing host cell anti-microbial activity, respectively. Both candidates are supported by data from preclinical and clinical studies. Co-primary efficacy endpoints will examine effects on lung function (measured by spirometry) and infection (measured as time to stable sputum culture conversion). A sub-study will examine quantitative change in lung radiodensity by CT scan. If successful, this ground-breaking project will increase Europe’s capacity to control RIF-R-TB by developing new treatments that increase the likelihood of cure and reduce the risk of life-long disability.

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The information about "DRTB-HDT" are provided by the European Opendata Portal: CORDIS opendata.

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