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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.

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

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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