Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

National Center for Research Resources (NCRR)1,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Cystic Fibrosis Atypical Mycobacterium Infection

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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