NCT00004296

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2000

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Cystic FibrosisAtypical Mycobacterium Infection

Keywords

atypical mycobacterium infectionbacterial infectioncardiovascular and respiratory diseasescystic fibrosisgenetic diseases and dysmorphic syndromesimmunologic disorders and infectious disordersmycobacterium infectionrare disease

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1128/jcm.35.10.2706-2708.1997.

    PMID: 9316943BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisMycobacterium Infections, NontuberculousBacterial InfectionsRespiratory Tract DiseasesGenetic Diseases, InbornImmune System DiseasesCommunicable DiseasesMycobacterium InfectionsRare Diseases

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial Infections and MycosesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ken Olivier

    University of North Carolina

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1995

Last Updated

June 24, 2005

Record last verified: 2000-01