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Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients



Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

For Condition: Cystic Fibrosis,Atypical Mycobacterium Infection
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of North Carolina
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Observational, Screening, Longitudinal
Minimum Age/Maximum Age: 10 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 1000

Location and Contact Information:

Overall Study Official:
KenOlivier,  Study Chair,  University of North Carolina


Additional Information:
Study ID Numbers:  199/11731;  UNCCH-939
Study Start Date: September 1995
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004296

Other Cystic Fibrosis Studies:
1. Interleukin-12 in the Treatment of Severe Nontuberculous Mycobacterial Infections

2. Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

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