Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease
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.
Nontuberculous Mycobacterial Disease,
Atypical Mycobacterium Infections
|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|
- 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:
- 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.
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
confirmed NTM patient
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.
- To determine prevalence of culture-confirmed NTM infection in the UIMC in a ten- year period
- To determine the prevalence of NTM disease based on ATS case definition the UIMC in a ten- year period
- To determine treatment outcome of NTM disease in the UIMC in a ten- year period
- To find the risk factors associated with treatment failure of patients with NTM diseases
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680822
|Contact: Mehdi Mirsaeidi, MD, MPHfirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60602|
|Contact: Mehdi Mirsaeidi, MD, MPH email@example.com|
|Principal Investigator: Mehdi Mirsaeidi, MD, MPH|
|Sub-Investigator: Dean Schraufnagel, MD|
|Principal Investigator:||Mehdi Mirsaeidi, MD, MPH||University of Illinois at Chicago|