Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients - Full Text View

Purpose

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.

Condition

Cystic Fibrosis
Atypical Mycobacterium Infection

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	1000
Study Start Date:	September 1995

Detailed 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.

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004296

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of North Carolina

Investigators


Study Chair:	Ken Olivier	University of North Carolina

More Information

Publications:

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.

Olivier KN.: Collaborative CFF/NCRR study of the epidemiology of nontuberculous mycobacteria in cystic fibrosis. Pediatric Pulmonology Suppl. 19: 145-146, 1999.

Study ID Numbers:	199/11731, UNCCH-939
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004296
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

atypical mycobacterium infection

bacterial infection

cardiovascular and respiratory diseases

cystic fibrosis

genetic diseases and dysmorphic syndromes

immunologic disorders and infectious disorders

mycobacterium infection

rare disease

Study placed in the following topic categories:

Bacterial Infections

Fibrosis

Respiration Disorders

Rare Diseases

Mycobacterium Infections, Atypical

Gram-Positive Bacterial Infections

Digestive System Diseases

Cystic Fibrosis

Respiratory Tract Diseases

Genetic Diseases, Inborn

Lung Diseases

Mycobacterium Infections

Pancreatic Diseases

Infant, Newborn, Diseases

Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

Infection

Actinomycetales Infections

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of North Carolina
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004296