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Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004296
Study type Observational
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase N/A
Start date September 1995
View Details
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