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Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00004296
Enrollment
1000
Registered
1999-10-19
Start date
1995-09-30
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Mycobacterium Infection, Cystic Fibrosis

Keywords

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

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.

Interventions

None listed

Sponsors

University of North Carolina
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Study design

Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026