Cough-Generated Aerosols of NTM in Cystic Fibrosis

NCT01815866 | Completed DMC

• 1 other identifier: 484-2012
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency. They have been demonstrated to cause clinically significant lung disease in some cases and the transmission of NTM, from person to person has been proposed. There are currently no standardized guidelines for isolation of those colonized or infected with NTM. The investigators will measure particle droplet size from patients with CF who have positive sputum cultures for NTM with the hypothesis that they will be in a range that can spread infection.

Conditions

Cystic Fibrosis

Keywords

Positive Nontuberculous Mycobacteria

Outcome Measures

Primary Outcomes (1)

• The number of CF patients who produce culturable aerosols of NTM during coughing.

  Patients with CF and a positive sputum or bronchoalveolar lavage (BAL) culture for NTM will cough into a chamber filled with culture plates that can measure droplet size. The investigators are looking for large droplets, that could land on surfaces and be a source for infection transmission, as well as fine droplets(5 microns or less)that are consistent with airborne transmission.

  6 weeks

Study Arms (1)

CF with culturable NTM

CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

Procedure: CF with culturable NTM

Interventions

CF with culturable NTM PROCEDURE

CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

CF with culturable NTM

Eligibility Criteria

• Age: 8 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Specialialty Clinics, Pulmonary

You may qualify if:

• Age greater than or equal to age 8 years
• Confirmed Diagnosis of CF
• Sputum/Throat/Bronchoscopic culture positive for NTM within the last 12 months

You may not qualify if:

• Pregnancy
• Pneumothorax within the last 6 months
• Forced Expiratory Volume at one second \<30% predicted
• Hemoptysis greater than 1 tablespoon within the last 7 days

Sponsors & Collaborators

• University of Florida: lead
• Children's Miracle Network: collaborator
• UF Peds: collaborator

Study Sites (1)

University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum cultures

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Pamela M Schuler, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (1)