Tuberculosis, Multidrug-resistant Clinical Trial
Official title:
Nosocomial Transmission of Multidrug-resistant Tuberculosis at the Marius Nasta Institute in Bucharest, Romania
Single-center, observational, prospective cohort study including patients hospitalized on the
multidrug-resistant tuberculosis ward at Marius Nasta Institute.
The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great
concern. The current study that will be conducted at the Marius Nasta Institute, one of two
nationwide excellence treatment centers for MDR-TB in Romania, is aiming to prospectively
investigate the population structure of patients with MDR-TB admitted for treatment and the
M. tuberculosis strains isolated from these patients. Transmission of MDR- strains of
Mycobacterium tuberculosis among patients hospitalized there will be also ascertained.
Additionally biomarkers for treatment response during the course of the tuberculosis therapy
will be evaluated.
The study will be conducted in a co-operation between the Marius Nasta Institute and the
German Center for Infection Research (DZIF).
Single-center, observational, prospective cohort study including all patients hospitalized on
the MDR-TB ward at Marius Nasta Institute.
An estimated 100 patients with MDR-TB consecutively admitted for treatment at the MNI will be
assessed for eligibility as study participants. All potential participants will be asked to
provide information on demographic, epidemiological and clinical characteristics as well as
prior treatment and disease history. Microbiological data, treatment and adverse events data
will also be recorded. The data is expected to supplement the existing body of knowledge
about patients with MDR-TB from the region.
In order to characterize M. tuberculosis strains, sputum samples will be collected from the
participants upon admission to the MDR-TB ward and after 3 months of therapy. Additionally,
subsequent samples identified as being positive after prior culture conversion will also
undergo testing. Key examinations on these samples include drug susceptibility testing on
solid media and molecular typing. If samples originating from the same patient show
discordance, whole genome sequencing will be performed to allow strain comparison between the
actual patient strain and those isolated from other patients to identify potential nosocomial
transmission. The location on ward of patients as well as their activities will also be
recorded in the scope of identifying possible routes of transmission.
Blood and urine samples will be collected at specific time points during the study and
further assessed in order to identify candidate biomarkers that are potentially correlated
with response to anti-tuberculosis therapy.
All data generated from this study will be collected on standardized study forms and entered
in a password-secured database.
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