Clinical Trial: Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title:
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: National Center for Research Resources (NCRR)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Office of Rare Diseases (ORD)
Dates:
Date Received: October 18, 1999
Date Started: September 1995
Date Completion:
Last Updated: June 23, 2005
Last Verified: January 2000