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NCT00004296 Clinical Trial

Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004296
Other study ID # 199/11731
Secondary ID UNCCH-939
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date September 1995

Study information
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

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.

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.

Recruitment information / eligibility
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

Study Design

Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of North Carolina

References & Publications (2)

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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