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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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004296

Sponsors and Collaborators
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
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:
Communicable Diseases
Cystic Fibrosis
Fibrosis
Infection
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Positive Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014