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The Incidence of Nontuberculous Mycobacterial Pulmonary Infection in Bilateral Bronchiectasis and Bronchiolitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01354912
First Posted: May 17, 2011
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now increasingly being recognized as significant causes of chronic pulmonary infection in immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide is caused by Mycobacterium avium-intracellular complex (MAC) (2-4).

In several studies with chest computed tomography (CT), researchers have demonstrated that the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11). Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT findings, however, may not be specific for NTM pulmonary infection. CT patterns of bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium xenopi, and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium fortuitum, and Mycobacterium chelonae (12-14). In addition, not all patients with bronchiectasis and bronchiolitis have NTM pulmonary infection. Two recent studies showed that only about 50% of patients with such CT features have MAC pulmonary infection (9,15). To the best of our knowledge, however, there is no report about the incidence of NTM in patients with bronchiectasis or bronchiolitis in countries with low incidence of TB. Thus, the purpose of our study was to determine the frequency of NTM pulmonary infection in patients with bilateral bronchiectasis and bronchiolitis at chest CT and to investigate whether these CT findings are specifically indicative of MAC infection or other specific pathogen.


Condition
Bronchiectasis Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The number of patients with NTM grouth among the the patients with double sided bronchiectasis or bronchiolitis. [ Time Frame: Two years ]

Estimated Enrollment: 150
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with bronchiectasis or bronchiolitis
Criteria

Inclusion Criteria:

  • All patients with bronchiectasis or bronchiolitis

Exclusion Criteria:

  • All patients with severe lung disease other than bronchiectasis
  • Active lung infection
  • Active infection other site except the lung
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354912


Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: David Shitrit, M.D    972-9-7472161    David.shitrit@clalit.org.il   
Principal Investigator: David Shitrit, M.D         
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01354912     History of Changes
Other Study ID Numbers: 2011-001
First Submitted: May 16, 2011
First Posted: May 17, 2011
Last Update Posted: March 12, 2013
Last Verified: March 2012

Keywords provided by Meir Medical Center:
mycobacterial infection
culture
ct scan

Additional relevant MeSH terms:
Bronchiolitis
Bronchiectasis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections