NCT00004296

Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Cystic Fibrosis
• Atypical Mycobacterium Infection

Timeline

• Start date: 1995-09-01
• First posted: 1999-10-19
• Last updated: 2005-06-24