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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.

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

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 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.	CH (Basel)	coordinator	1˙155˙060.00
2	THE AURUM INSTITUTE NPC THE AURUM INSTITUTE NPC Organization address address: THE RIDGE 29 QUEENS ROAD city: PARKTOWN JOHANNESBURG postcode: 2193 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ZA (PARKTOWN JOHANNESBURG)	participant	3˙200˙656.00
3	WITS HEALTH CONSORTIUM (PTY) LTD WITS HEALTH CONSORTIUM (PTY) LTD Organization address address: Princess of Wales Terrace, Parktown, 31 city: Johannesburg postcode: 2193 website: www.witshealth.co.za contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ZA (Johannesburg)	participant	1˙752˙440.00
4	Instituto Nacional de Saúde Instituto Nacional de Saúde Organization address address: Avenida Eduardo Mondlane 1008 city: Maputo postcode: n.a. website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	MZ (Maputo)	participant	868˙332.00
5	LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN Organization address address: GESCHWISTER SCHOLL PLATZ 1 city: MUENCHEN postcode: 80539 website: www.uni-muenchen.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (MUENCHEN)	participant	808˙922.00
6	FORSCHUNGSZENTRUM BORSTEL FORSCHUNGSZENTRUM BORSTEL Organization address address: Parkallee 1-40 city: BORSTEL postcode: 23845 website: www.fz-borstel.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BORSTEL)	participant	753˙750.00
7	NATIONAL CENTER FOR TUBERCULOSIS AND LUNG DISEASES JSC NATIONAL CENTER FOR TUBERCULOSIS AND LUNG DISEASES JSC Organization address address: 8 ADJARA city: TBILISI postcode: 101 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	GE (TBILISI)	participant	618˙000.00
8	INSTITUTUL DE PNEUMOFTIZIOLOGIE MARIUS NASTA INSTITUTUL DE PNEUMOFTIZIOLOGIE MARIUS NASTA Organization address address: SOSEAUA VIILOR 90 SECTOR 5 city: BUCURESTI postcode: 50159 website: www.mariusnasta.ro contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	RO (BUCURESTI)	participant	353˙750.00
9	UNIVERSITEIT ANTWERPEN UNIVERSITEIT ANTWERPEN Organization address address: PRINSSTRAAT 13 city: ANTWERPEN postcode: 2000 website: www.ua.ac.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (ANTWERPEN)	participant	275˙199.00
10	"INSTITUTIA MEDICO-SANITARA PUBLICA - INSTITUTUL DE FTIZIOPNEUMOLOGIE ""CHIRIL DRAGANIUC""" "INSTITUTIA MEDICO-SANITARA PUBLICA - INSTITUTUL DE FTIZIOPNEUMOLOGIE ""CHIRIL DRAGANIUC""" Organization address address: STRADA VIRNAV C 13 city: CHISINAU postcode: 2025 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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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