Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:September 2012
Contact:Mehdi Mirsaeidi, MD, MPH
Email:mmirsae@uic.edu
Phone:312-996-8039

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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.

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

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.
We found this trial at
1
site
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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