Multicenter Study of Nontuberculous Mycobacteria in Cystic Fibrosis Patients

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.

Completed

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Key information

Conditions

Cystic Fibrosis Actinomycetales Infections Atypical Mycobacterium Infection Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Gram-Positive Bacterial Infections Immune System Diseases Infant, Newborn, Diseases Infections Lung Diseases Mycobacterium Infections Mycobacterium Infections, Nontuberculous Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Respiratory Tract Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of North Carolina

Registry information

Important dates

Study start: 1995
First posted: Oct 19, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed