Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

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

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

Study Type:	Observational
Study Design:	Primary Purpose: Screening Time Perspective: Longitudinal

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Bacterial Infections Cystic Fibrosis Mycobacterial Infections

U.S. FDA Resources

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.

ClinicalTrials.gov Identifier:	NCT00004296 History of Changes
Other Study ID Numbers:	199/11731, UNCCH-939
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Mycobacterium Infections
Mycobacterium Infections, Atypical
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012