Text Size

Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004296
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Olivier KN.: Collaborative CFF/NCRR study of the epidemiology of nontuberculous mycobacteria in cystic fibrosis. Pediatric Pulmonology Suppl. 19: 145-146, 1999.

ClinicalTrials.gov Identifier: NCT00004296     History of Changes
Other Study ID Numbers: 199/11731, UNCCH-939
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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:
Cystic Fibrosis
Fibrosis
Mycobacterium Infections
Mycobacterium Infections, Atypical
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013