Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease

• ClinicalTrials.gov Identifier: NCT01680822
• Recruitment Status: Completed
• First Posted: September 7, 2012
• Last Update Posted: November 18, 2014
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Mehdi Mirsaeidi MD, MPH, University of Illinois at Chicago

Study Description

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.

Condition or disease
Nontuberculous Mycobacterial Disease,; Atypical Mycobacterium Infections

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 Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• 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
• Study Start Date: September 2012
• Actual Primary Completion Date: November 2014

Groups and Cohorts

Group/Cohort
NTM patient; confirmed NTM patient

Outcome Measures

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60602

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

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

More Information

Publications:

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.

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.

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. Review.

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.

• Responsible Party: Mehdi Mirsaeidi MD, MPH, Fellow, Pulmonary and Critical Care, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT01680822
• Other Study ID Numbers: 2012-0662; UIC ( Other Identifier: University of Illinois at Chicago )
• First Posted: September 7, 2012
• Last Update Posted: November 18, 2014
• Last Verified: November 2014

Keywords provided by Mehdi Mirsaeidi MD, MPH, 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; Bacterial Infections and Mycoses; Infections