Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease

May 3, 2023 updated by: Erin Vidra, University of Illinois at Chicago

Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease in the University of Illinois Hospital & Health Sciences System

Little is known about the disease caused by the nontuberculous or environmental mycobacteria (NTM) and only limited data are available showing treatment outcome. This project will study the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois Hospital & Health Sciences System (UIMC). The aim of study is finding treatment outcome and risk factors that are associated with treatment failure in NTM patients. This is a retrospective, observational study for collecting data on patients with NTM in UIMC. The study initially involves populating the study of NTM patients seen at UIMC during the study period. This will add our knowledge about current treatment outcome of patients with NTM diseases and will be of interest to physicians, and public health authorities.

Study Overview

Status

Terminated

Conditions

Detailed Description

The study focuses on collecting all mycobacterial data, clinical assessment and clinical outcomes of patients. Data collection includes demographic characteristics, medical history, clinical procedures relative to the treatment of NTM, respiratory symptoms and signs, pulmonary function tests if applicable, imaging parameters, diagnostic tests, mycobacterial smear, culture, or possible susceptibility, therapies and outcome. The study will be updated with clinical outcomes (e.g., hospitalization, surgery relative NTM, and death) during study period. The data will be collected from 1/1/2001 to 12/30/ 2011.

The confirmed NTM patient will be defined with ATS guideline for NTM as:

Clinical: Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or an HRCT scan that shows multifocal bronchiectasis with multiple small nodules and 2. appropriate exclusion of other diagnoses.

Microbiologic: Positive culture results from at least two separate expectorated sputum samples. (If the results from the initial sputum samples are nondiagnostic, we will consider repeat sputum AFB smears and cultures.) Or positive culture results from at least one bronchial wash or lavage. Or transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or AFB) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washings that are culture positive for NTM.

OBJECTIVES

  1. To determine prevalence of culture-confirmed NTM infection in the UIMC in a ten- year period
  2. To determine the prevalence of NTM disease based on ATS case definition the UIMC in a ten- year period
  3. To determine treatment outcome of NTM disease in the UIMC in a ten- year period
  4. To find the risk factors associated with treatment failure of patients with NTM diseases

Study Type

Observational

Enrollment (Actual)

150

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60602
        • University of Illinois at Chicago

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who were seeking or receiving medical care for NTM disease at UIC Medical Center that satisfy the inclusion and exclusion criteria of study are eligible to participation.

Description

Inclusion Criteria:

  • Aged 18 year or older with at least one culture-confirmed NTM.

Exclusion Criteria:

  • All patients aged younger than 18 years old.
  • No individuals are excluded from study based on, race, ethnicity, gender, or HIV status.

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
NTM patient
confirmed NTM patient

What is the study measuring?

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine treatment outcomes of a thousand subjects with NTM disease in a three-year period
Time Frame: Participants will be followed for the duration of three years after starting treatment.

The outcomes of NTM disease are defined as:

  • ALIVE:

    • Cure (at least 12 months treatment after three negative sputum cultures).
    • Incomplete treated (patient has not followed the treatment).
    • No treatment has been offered to the patient.
    • Patient has culture positive after 6 months of treatment.
    • Patient has culture positive after 12 months of treatment.
    • After 24 months treatment patient still is culture positive.
    • Patient is only contaminated; no treatment is indicated.

  • DEAD during first 24 months of treatment:

    • Death due to NTM
    • Death unrelated to NTM
  • Patients will be followed for 3 years after diagnosis made.
Participants will be followed for the duration of three years after starting treatment.

Collaborators and Investigators

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

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Mehdi Mirsaeidi, MD, MPH, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-0662
  • UIC (University of Illinois at Chicago)

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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