Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease

NCT ID: NCT01680822

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

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

Conditions

Nontuberculous Mycobacterial Disease; Atypical Mycobacterium Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

NTM patient

confirmed NTM patient

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Erin Vidra

Fellow, Pulmonary and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehdi Mirsaeidi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

Tabarsi P, Baghaei P, Farnia P, Mansouri N, Chitsaz E, Sheikholeslam F, Marjani M, Rouhani N, Mirsaeidi M, Alipanah N, Amiri M, Masjedi MR, Mansouri D. Nontuberculous mycobacteria among patients who are suspected for multidrug-resistant tuberculosis-need for earlier identification of nontuberculosis mycobacteria. Am J Med Sci. 2009 Mar;337(3):182-4. doi: 10.1097/maj.0b013e318185d32f.

Reference Type: BACKGROUND

PMID: 19301453 (View on PubMed)

Mirsaeidi M, Hadid W, Ericsoussi B, Rodgers D, Sadikot RT. Non-tuberculous mycobacterial disease is common in patients with non-cystic fibrosis bronchiectasis. Int J Infect Dis. 2013 Nov;17(11):e1000-4. doi: 10.1016/j.ijid.2013.03.018. Epub 2013 May 16.

Reference Type: BACKGROUND

PMID: 23683809 (View on PubMed)

Mirsaeidi M, Farshidpour M, Ebrahimi G, Aliberti S, Falkinham JO 3rd. Management of nontuberculous mycobacterial infection in the elderly. Eur J Intern Med. 2014 Apr;25(4):356-63. doi: 10.1016/j.ejim.2014.03.008. Epub 2014 Mar 29.

Reference Type: BACKGROUND

PMID: 24685313 (View on PubMed)

Mirsaeidi M, Machado RF, Garcia JG, Schraufnagel DE. Nontuberculous mycobacterial disease mortality in the United States, 1999-2010: a population-based comparative study. PLoS One. 2014 Mar 14;9(3):e91879. doi: 10.1371/journal.pone.0091879. eCollection 2014.

Reference Type: BACKGROUND

PMID: 24632814 (View on PubMed)

Other Identifiers

UIC

Identifier Type: OTHER

Identifier Source: secondary_id

2012-0662

Identifier Type: -

Identifier Source: org_study_id