Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004296 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Official Title ^ICMJE

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Longitudinal

Condition ^ICMJE

Cystic Fibrosis
Atypical Mycobacterium Infection

Intervention ^ICMJE

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004296

Responsible Party

Study ID Numbers ^ICMJE

199/11731, UNCCH-939

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of North Carolina

Investigators ^ICMJE

Study Chair:

Ken Olivier

University of North Carolina

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP