<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680822</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0662</org_study_id>
    <secondary_id>UIC</secondary_id>
    <nct_id>NCT01680822</nct_id>
  </id_info>
  <brief_title>Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease</brief_title>
  <official_title>Treatment Outcomes in Patient With Nontuberculous Mycobacterial Disease in the University of Illinois Hospital &amp; Health Sciences System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known about the disease caused by the nontuberculous or environmental mycobacteria&#xD;
      (NTM) and only limited data are available showing treatment outcome. This project will study&#xD;
      the patients with nontuberculous mycobacterial (NTM) diseases in the University of Illinois&#xD;
      Hospital &amp; Health Sciences System (UIMC). The aim of study is finding treatment outcome and&#xD;
      risk factors that are associated with treatment failure in NTM patients. This is a&#xD;
      retrospective, observational study for collecting data on patients with NTM in UIMC. The&#xD;
      study initially involves populating the study of NTM patients seen at UIMC during the study&#xD;
      period. This will add our knowledge about current treatment outcome of patients with NTM&#xD;
      diseases and will be of interest to physicians, and public health authorities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study focuses on collecting all mycobacterial data, clinical assessment and clinical&#xD;
      outcomes of patients. Data collection includes demographic characteristics, medical history,&#xD;
      clinical procedures relative to the treatment of NTM, respiratory symptoms and signs,&#xD;
      pulmonary function tests if applicable, imaging parameters, diagnostic tests, mycobacterial&#xD;
      smear, culture, or possible susceptibility, therapies and outcome. The study will be updated&#xD;
      with clinical outcomes (e.g., hospitalization, surgery relative NTM, and death) during study&#xD;
      period. The data will be collected from 1/1/2001 to 12/30/ 2011.&#xD;
&#xD;
      The confirmed NTM patient will be defined with ATS guideline for NTM as:&#xD;
&#xD;
      Clinical: Pulmonary symptoms, nodular or cavitary opacities on chest radiograph, or an HRCT&#xD;
      scan that shows multifocal bronchiectasis with multiple small nodules and 2. appropriate&#xD;
      exclusion of other diagnoses.&#xD;
&#xD;
      Microbiologic: Positive culture results from at least two separate expectorated sputum&#xD;
      samples. (If the results from the initial sputum samples are nondiagnostic, we will consider&#xD;
      repeat sputum AFB smears and cultures.) Or positive culture results from at least one&#xD;
      bronchial wash or lavage. Or transbronchial or other lung biopsy with mycobacterial&#xD;
      histopathologic features (granulomatous inflammation or AFB) and positive culture for NTM or&#xD;
      biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and&#xD;
      one or more sputum or bronchial washings that are culture positive for NTM.&#xD;
&#xD;
      OBJECTIVES&#xD;
&#xD;
        1. To determine prevalence of culture-confirmed NTM infection in the UIMC in a ten- year&#xD;
           period&#xD;
&#xD;
        2. To determine the prevalence of NTM disease based on ATS case definition the UIMC in a&#xD;
           ten- year period&#xD;
&#xD;
        3. To determine treatment outcome of NTM disease in the UIMC in a ten- year period&#xD;
&#xD;
        4. To find the risk factors associated with treatment failure of patients with NTM diseases&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI left institution, not able to contact; data destroyed&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Nontuberculous Mycobacterial Disease</condition>
  <condition>Atypical Mycobacterium Infections</condition>
  <arm_group>
    <arm_group_label>NTM patient</arm_group_label>
    <description>confirmed NTM patient</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were seeking or receiving medical care for NTM disease at UIC Medical Center&#xD;
        that satisfy the inclusion and exclusion criteria of study are eligible to participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 year or older with at least one culture-confirmed NTM.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients aged younger than 18 years old.&#xD;
&#xD;
          -  No individuals are excluded from study based on, race, ethnicity, gender, or HIV&#xD;
             status.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehdi Mirsaeidi, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>Iran, Islamic Republic of</country>
    <country>Italy</country>
    <country>Taiwan</country>
  </removed_countries>
  <reference>
    <citation>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.</citation>
    <PMID>19301453</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23683809</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24685313</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24632814</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Erin Vidra</investigator_full_name>
    <investigator_title>Fellow, Pulmonary and Critical Care</investigator_title>
  </responsible_party>
  <keyword>Nontuberculous, Atypical, Mycobacterial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycobacterium Infections</mesh_term>
    <mesh_term>Mycobacterium Infections, Nontuberculous</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680822
org study id: 2012-0662
secondary id: UIC
nct id: NCT01680822
lead sponsor: 
has dmc: No
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
observational model: Cohort
time perspective: Retrospective
arm group label: NTM patient
description: confirmed NTM patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mehdi Mirsaeidi, MD, MPH
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
country: Argentina
country: Croatia
country: Denmark
country: Iran, Islamic Republic of
country: Italy
country: Taiwan
citation: 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.
PMID: 19301453
citation: 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.
PMID: 23683809
citation: 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.
PMID: 24685313
citation: 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.
PMID: 24632814
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Erin Vidra
investigator title: Fellow, Pulmonary and Critical Care
mesh term: Mycobacterium Infections
mesh term: Mycobacterium Infections, Nontuberculous