Cystic Fibrosis Clinical Trial
Verified date | January 2000 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
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 |
Primary Purpose: Screening, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Center for Research Resources (NCRR) | University of North Carolina |
Olivier KN.: Collaborative CFF/NCRR study of the epidemiology of nontuberculous mycobacteria in cystic fibrosis. Pediatric Pulmonology Suppl. 19: 145-146, 1999.
Whittier S, Olivier K, Gilligan P, Knowles M, Della-Latta P. Proficiency testing of clinical microbiology laboratories using modified decontamination procedures for detection of nontuberculous mycobacteria in sputum samples from cystic fibrosis patients. The Nontuberculous Mycobacteria in Cystic Fibrosis Study Group. J Clin Microbiol. 1997 Oct;35(10):2706-8. — View Citation
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