Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
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.
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