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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT02413931 |
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Date of registration:
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17/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nosocomial Transmission of MDR-TB in Bucharest, Romania
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Scientific title:
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Nosocomial Transmission of Multidrug-resistant Tuberculosis at the Marius Nasta Institute in Bucharest, Romania |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02413931 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Romania
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Contacts
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Name:
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Christoph Lange, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center Borstel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects with confirmed pulmonary MDR-TB
2. Subject able and willing to give informed consent
Exclusion Criteria:
1. physical or mental inability preventing study participation at the discretion of the
investigator
2. member of a vulnerable or special population (prisoner, soldier, mentally ill, under
guardianship,
3. age <18 years.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tuberculosis, Multidrug-resistant
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Intervention(s)
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Other: Routine management practices applied
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Primary Outcome(s)
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Number of patients with nosocomially transmitted MDR-TB
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Secondary Outcome(s)
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Proportion of patients with cardio-pulmonary impairment at different time points
[Time Frame: until the end of treatment - ca. 48 months after enrolment]
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Proportion of patients with co-morbidities and co-infections
[Time Frame: until the end of treatment - ca. 48 months after enrolment]
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Concordance between phenotypic drug susceptibility testing and detected resistance mutations
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Proportion of patients with changes in drug susceptibility pattern during treatment
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Proportion of patients with socio-economic and psychological adverse outcomes
[Time Frame: until the end of treatment - ca. 48 months after enrolment]
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Number of patients with different TB genotypes (e.g. Beijing, LAM, EAI, etc.)
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Clustering within the MDR-TB patient population
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Proportion of patients with mixed infections
[Time Frame: until the end of treatment - ca. 20 months after enrolment]
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Secondary ID(s)
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RCBorstel_MNI_001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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