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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.

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

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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