Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-09-30

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Atypical Mycobacterium Infection

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ken Olivier

Role: STUDY_CHAIR

University of North Carolina

References

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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.

Reference Type BACKGROUND

PMID: 9316943 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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UNCCH-939

Identifier Type: -

Identifier Source: secondary_id

199/11731