Nosocomial Transmission of MDR-TB in Bucharest, Romania

NCT02413931 | Completed

• 1 other identifier: RCBorstel_MNI_001
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-center, observational, prospective cohort study recruiting patients hospitalized at the multidrug-resistant tuberculosis ward at Marius Nasta Institute. This project aims to improve the individual patient management and TB treatment outcomes, especially for patients with drug-resistant TB and/or co-morbidities. The study will be conducted in a co-operation between the Marius Nasta Institute, Division of Infectious Diseases \& Tropical Medicine of Klinikum of the University of Munich (KUM) and the German Center for Infection Research (DZIF).

Conditions

Tuberculosis, Multidrug-resistant

Keywords

tuberculosis; MDR-TB

Outcome Measures

Primary Outcomes (1)

• Number of patients with nosocomially transmitted MDR-TB

  until the end of treatment - ca. 20 months after enrolment

Secondary Outcomes (8)

• Concordance between phenotypic drug susceptibility testing and detected resistance mutations

  until the end of treatment - ca. 20 months after enrolment

• Proportion of patients with changes in drug susceptibility pattern during treatment

  until the end of treatment - ca. 20 months after enrolment

• Proportion of patients with mixed infections

  until the end of treatment - ca. 20 months after enrolment

• Clustering within the MDR-TB patient population

  until the end of treatment - ca. 20 months after enrolment

• Number of patients with different TB genotypes (e.g. Beijing, LAM, EAI, etc.)

  until the end of treatment - ca. 20 months after enrolment

Study Arms (1)

Patients with MDR-TB

Patients with multidrug-resistant tuberculosis admitted for treatment at the Marius Nasta Institute will be included

Other: Routine management practices applied

Interventions

Routine management practices applied OTHER

all patients will be treated according to routine procedures, no intervention

Patients with MDR-TB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with microbiologically confirmed pulmonary MDR-TB admitted to the MDR-TB ward of the Marius Nasta Instiute

You may qualify if:

• Subjects with confirmed pulmonary MDR-TB
• Subject able and willing to give informed consent

You may not qualify if:

• physical or mental inability preventing study participation at the discretion of the investigator
• member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship,
• age \<18 years.

Sponsors & Collaborators

• Research Center Borstel: lead
• "Marius Nasta" Pulmonology Institute: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Marius Nasta Pulmonology Institute

Bucharest, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum, blood and urine samples

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Christoph Lange, MD, PhD

  Research Center Borstel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief investigator

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 10, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

RO (1)