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Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Illinois at Chicago
Sponsor:
Information provided by (Responsible Party):
Mehdi Mirsaeidi MD, MPH, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01680822
First received: August 31, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition
Nontuberculous Mycobacterial Disease,
Atypical Mycobacterium Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease in the University of Illinois Hospital & Health Sciences System

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 1000
Study Start Date: September 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
NTM patient
confirmed NTM patient

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680822

Contacts
Contact: Mehdi Mirsaeidi, MD, MPH 312-996-8039 mmirsae@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60602
Contact: Mehdi Mirsaeidi, MD, MPH       mmirsae@uic.edu   
Principal Investigator: Mehdi Mirsaeidi, MD, MPH         
Sub-Investigator: Dean Schraufnagel, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Mehdi Mirsaeidi, MD, MPH University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Mehdi Mirsaeidi MD, MPH, Fellow, Pulmonary and Critical Care, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01680822     History of Changes
Other Study ID Numbers: 2012-0662, UIC
Study First Received: August 31, 2012
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Nontuberculous, Atypical, Mycobacterial

Additional relevant MeSH terms:
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 19, 2014