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Clinical Trial Summary

The study is an exploratory clinical trial to evaluate the efficacy and safety of the treatment with a vaccine against tuberculosis (RUTI®) given at the same time as standard treatment in patients with tuberculosis. It is a prospective, randomized (1:1), double-blind, multicentre, placebo-controlled clinical phase IIb trial.


Clinical Trial Description

Patients will be randomized (1: 1) to receive an inoculation of RUTI® or placebo at the same time that standard treatment is started. The standard TB treatment will continue after RUTI® or placebo administration according to SOC guidelines. All the patients will be followed up 6 months after the vaccination or until the end of SOC treatment. Once all the patients have completed the week 2 follow-up, a Data Safety Monitoring Board (DSMB) will be established to review all relevant safety and toxicity data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05136833
Study type Interventional
Source Archivel Farma S.L.
Contact
Status Withdrawn
Phase Phase 2
Start date December 1, 2021
Completion date December 31, 2022

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