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Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004296
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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.
Collaborator:
University of North Carolina
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES: I. Determine the prevalence of nontuberculous mycobacteria in sputum cultures from patients with cystic fibrosis.

II. Compare the clinical course of patients with negative versus positive cultures.


Condition
Cystic Fibrosis Atypical Mycobacterium Infection

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Longitudinal

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 1000
Study Start Date: September 1995
Detailed Description:

PROTOCOL OUTLINE: Participants are screened for nontuberculous mycobacteria (NTM) with 3 sputum acid-fast bacilli smears and mycobacterial cultures, with speciation of positive cultures, collected over 1 year. Demographic data, diagnostic criteria, clinical measurements, and other respiratory pathogen data are collected using the Cystic Fibrosis Foundation Patient Registry Questionnaire.

NTM-positive patients (cases) matched with NTM-negative controls identified in screening are followed every 3 months for 15 months. Cases are evaluated for NTM burden during the first 3 months.

Appropriate therapy is offered to consistently NTM-positive cases. Lung transplant recipients are removed from study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

Patients over age 10 with cystic fibrosis documented as follows:

  • Pilocarpine sweat chloride test at least 60 mEq/L OR
  • Genotyping or transepithelial potential difference AND
  • Clinical symptoms of suppurative respiratory disease or pancreatic insufficiency

Able to produce at least 3 sputum samples

  • Bronchoscopy specimens acceptable
  • Throat/nasal specimens not acceptable

No Pseudomonas cepacia colonization

  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): NCT00004296


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of North Carolina
Investigators
Study Chair: Ken Olivier University of North Carolina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004296     History of Changes
Other Study ID Numbers: 199/11731
UNCCH-939
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
Last Verified: January 2000

Keywords provided by Office of Rare Diseases (ORD):
atypical mycobacterium infection
bacterial infection
cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
immunologic disorders and infectious disorders
mycobacterium infection
rare disease

Additional relevant MeSH terms:
Infection
Fibrosis
Cystic Fibrosis
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections