000883183 001__ 883183
000883183 005__ 20230213130348.0
000883183 0247_ $$2CORDIS$$aG:(EU-Grant)847465$$d847465
000883183 0247_ $$2CORDIS$$aG:(EU-Call)H2020-SC1-2019-Two-Stage-RTD$$dH2020-SC1-2019-Two-Stage-RTD
000883183 0247_ $$2originalID$$acorda__h2020::847465
000883183 035__ $$aG:(EU-Grant)847465
000883183 150__ $$aSTRATIFIED HOST-DIRECTED THERAPY FOR DRUG-RESISTANT TUBERCULOSIS: A RANDOMIZED CONTROLLED MULTI-CENTRE TRIAL$$y2020-01-01 - 2023-12-31
000883183 371__ $$aINSTITUTUL DE PNEUMOFTIZIOLOGIE MARIUS NASTA$$bIPMN$$dRomania$$ehttp://www.marius-nasta.ro$$vCORDIS
000883183 371__ $$aINSTITUTIA MEDICO-SANITARA PUBLICA - INSTITUTUL DE FTIZIOPNEUMOLOGIE "CHIRIL DRAGANIUC"$$bIFP CHIRIL DRAGANIUC$$dMoldova (Republic of)$$ehttp://www.ifp.asm.md$$vCORDIS
000883183 371__ $$aTHE AURUM INSTITUTE NPC$$dSouth Africa$$ehttp://www.auruminstititute.org$$vCORDIS
000883183 371__ $$aNATIONAL CENTER FOR TUBERCULOSIS AND LUNG DISEASES JSC$$bNCTLD$$dGeorgia$$ehttp://www.tbgeo.ge$$vCORDIS
000883183 371__ $$aWITS HEALTH CONSORTIUM (PTY) LTD$$bWHC$$dSouth Africa$$ehttp://www.witshealth.co.za$$vCORDIS
000883183 371__ $$aLUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN$$bLMU MUENCHEN$$dGermany$$ehttp://www.uni-muenchen.de$$vCORDIS
000883183 371__ $$aInstituto Nacional de Saúde$$bINS$$dMozambique$$ehttp://www.ins.gov.mz/$$vCORDIS
000883183 371__ $$aSchweizerisches Tropeninstitut Medical Department Medical Diagnostics$$bSWISS TPH$$dSwitzerland$$ehttp://www.swisstph.ch$$vCORDIS
000883183 371__ $$aUniversity of Antwerp$$bUniversity of Antwerp$$dBelgium$$ehttps://www.uantwerpen.be/en/$$vCORDIS
000883183 371__ $$aFORSCHUNGSZENTRUM BORSTEL$$bFZB$$dGermany$$ehttp://www.fz-borstel.de$$vCORDIS
000883183 372__ $$aH2020-SC1-2019-Two-Stage-RTD$$s2020-01-01$$t2023-12-31
000883183 450__ $$aDRTB-HDT$$wd$$y2020-01-01 - 2023-12-31
000883183 5101_ $$0I:(DE-588b)5098525-5$$2CORDIS$$aEuropean Union
000883183 680__ $$aTuberculosis 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.
000883183 909CO $$ooai:juser.fz-juelich.de:883183$$pauthority$$pauthority:GRANT
000883183 970__ $$aoai:dnet:corda__h2020::49684269b5f142564183f0d57b95ec4c
000883183 980__ $$aG
000883183 980__ $$aCORDIS
000883183 980__ $$aAUTHORITY