Nosocomial Transmission of MDR-TB in Bucharest, Romania

April 9, 2024 updated by: Christoph Lange, Research Center Borstel

Nosocomial Transmission of Multidrug-resistant Tuberculosis at the Marius Nasta Institute in Bucharest, Romania

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although in Germany tuberculosis (TB) is becoming a rare disease, TB continues to represent a major cause of morbidity and mortality worldwide. According to the World Health Organization, more than 10 million TB cases were registered worldwide leading to 1.8 million deaths. In the absence of a vaccine that is more effective to prevent TB than the M. bovis Bacille Calmette Guérin vaccine, TB prevention will rely on early case detection and preventive therapies for individuals who are latently infected with M. tuberculosis. Treatment of active TB requires taking a combination of anti-mycobacterial drugs for a very long time to achieve relapse-free cure. Current international guidelines recommend treatment for pan-drug susceptible pulmonary TB for 6 months, more importantly, a total of 20 months is recommended for treatment of patients with M/XDR-TB. These general recommendations are not applicable to the majority of affected patients. A substantial proportion of patients with TB will achieve relapse-free cure with shorter durations of anti-mycobacterial treatments. However, biomarkers that guide clinicians to decide on the individual duration of TB therapy are lacking. Optimal duration of TB treatment depends on a variety of variables, such as the extent of disease, the immune-status of the host, co-morbidities/infections, drug-resistance and virulence of the causative bacilli, and availability of anti-mycobacterial drugs. For many patients, especially those affected by M/XDR-TB, the long duration of therapy is related to substantial morbidity and loss of quality of life due to adverse events of the treatment.

This project has the goal to further the development of the previously established good clinical practice (GCP)-conform clinical study site at the Marius Nasta Institute (MNI) in Bucharest, Romania. The Eastern European Study Site will represent and important partner and support the conduction of a number of studies within other work packages as well as continue the enrollment of patients with multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) started earlier. The characteristics of patients with M/XDR-TB and co-morbidities of patients with TB will be recorded and their influence on patient outcome will be analyzed. In this setting, biomarkers that could help individualize the duration of anti-tuberculosis therapy and that could offer an early prediction of treatment outcome will be validated. The study site could also provide a platform for the conduction of studies aimed at developing and standardizing a system of drug-level monitoring (therapeutic drug monitoring) for TB. The project will therefore support studies with the goal of individualizing therapy for TB and represent a valuable international DZIF-partner in a medium-TB-incidence setting. Within this project, the partnership with the good clinical practice (GCP)-conform Eastern European Study Site at the Marius Nasta Institute MNI) in Bucharest, Romania will be continued. The MNI is the country-wide referral center for the treatment of M/XDR-TB in Romania and hosts the Romanian Reference Laboratory for Mycobacteria.

This project aims to improve the individual patient management and TB treatment outcomes, especially for patients with drug-resistant TB and/or co-morbidities. This will be achieved by:

  • Identify characteristics of patients with M/XDR-TB from the MNI. This could potentially lead to the identification of risk factors associated with drug-resistant TB in Romania, predictors of an unsuccessful treatment outcome, as well as record management practices of patients with M/XDR-TB.
  • Analysis of transmission routes and molecular drug-resistance profiles of M. tuberculosis strains isolated from M/XDR to differentiate between nosocomial and community acquired infections.
  • Further development of the already established GCP-conform Eastern European Study Site.
  • Identification and validation of bio-signatures to allow treatment outcome prediction and evaluation of markers that will eventually guide clinicians for decisions on the durations of therapy
  • Evaluation of co-morbidities/infections and inflammation status on TB treatment outcome
  • Evaluation of cardio-pulmonary TB-outcome (e.g. lung function) as a clinical marker to describe treatment success/treatment outcome
  • Evaluation of neutrophils as targets for host-directed therapies and neutrophil signatures from bronchial secretions for point-of-care diagnosis
  • Evaluation of lipids as targets for host-directed therapies and lipid signatures from bronchial secretions for point-of-care diagnosis
  • Establishment and evaluation of therapeutic drug monitoring techniques for anti-mycobacterial therapy regimens

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • Marius Nasta Pulmonology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
all patients will be treated according to routine procedures, no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients with nosocomially transmitted MDR-TB
Time Frame: until the end of treatment - ca. 20 months after enrolment
until the end of treatment - ca. 20 months after enrolment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Concordance between phenotypic drug susceptibility testing and detected resistance mutations
Time Frame: until the end of treatment - ca. 20 months after enrolment
until the end of treatment - ca. 20 months after enrolment
Proportion of patients with changes in drug susceptibility pattern during treatment
Time Frame: until the end of treatment - ca. 20 months after enrolment
until the end of treatment - ca. 20 months after enrolment
Proportion of patients with mixed infections
Time Frame: until the end of treatment - ca. 20 months after enrolment
until the end of treatment - ca. 20 months after enrolment
Clustering within the MDR-TB patient population
Time Frame: until the end of treatment - ca. 20 months after enrolment
until the end of treatment - ca. 20 months after enrolment
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
until the end of treatment - ca. 20 months after enrolment
Proportion of patients with cardio-pulmonary impairment at different time points
Time Frame: until the end of treatment - ca. 48 months after enrolment
until the end of treatment - ca. 48 months after enrolment
Proportion of patients with socio-economic and psychological adverse outcomes
Time Frame: until the end of treatment - ca. 48 months after enrolment
until the end of treatment - ca. 48 months after enrolment
Proportion of patients with co-morbidities and co-infections
Time Frame: until the end of treatment - ca. 48 months after enrolment
until the end of treatment - ca. 48 months after enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Research Center Borstel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ludwig-Maximilians - University of Munich
"Marius Nasta" Pulmonology Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christoph Lange, MD, PhD, Research Center Borstel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCBorstel_MNI_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

this will be decided at a later time point

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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