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STRATIFIED HOST-DIRECTED THERAPY FOR DRUG-RESISTANT TUBERCULOSIS: A RANDOMIZED CONTROLLED MULTI-CENTRE TRIAL

Project description

Clinical trial of host-directed therapy for drug-resistant tuberculosis

Tuberculosis (TB) is a leading causes of morbidity and mortality worldwide. Current TB treatments are long, complex and often poorly tolerated; moreover, cases of the rifampicin-resistant (RIF-R) form of TB magnify this global health threat. The EU-funded DRTB-HDT project will determine if two adjunctive host-directed therapies can prevent the poor outcomes of treatment in cases of RIF-R TB. Patients with RIF-R TB and risk factors for poor outcome will participate in a randomised, controlled, three-armed multicentre trial. All patients will receive standard multidrug therapy; the experimental arms will additionally receive either CC-11050 or metformin. These selected drug candidates represent two complementary host-directed therapy strategies: reducing inflammation or inducing host cell anti-microbial activity, respectively. If the trial is a success, DRTB-HDT will improve the capacity to control RIF-R TB, thereby increasing the likelihood of its cure.

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 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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Topic(s)

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

SCHWEIZERISCHES TROPEN UND PUBLIC HEALTH INSTITUT
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 774 420,31
Address
KREUZSTRASSE 2
4123 ALLSCHWIL
Switzerland

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Landschaft
Activity type
Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 774 420,31

Participants (9)

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