Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients
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|ClinicalTrials.gov Identifier: NCT00004296|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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 or disease|
|Cystic Fibrosis Atypical Mycobacterium Infection|
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 Type :||Observational|
|Enrollment :||1000 participants|
|Study Start Date :||September 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004296
|Study Chair:||Ken Olivier||University of North Carolina|