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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.

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

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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