Cough-Generated Aerosols of NTM in Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

8 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States

About this study

Patients with a positive NTM sputum culture will be asked to participate in the study. If they agree to participate they will sign an informed consent and will be scheduled to come to the University of Florida Clinical Research Center for the testing.

The test will consist of the following: 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.

Patients maybe asked to come back a second time if they develop a different type of NTM or start treatment for NTM.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 6 weeks

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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Children's Miracle Network
UF Peds

Registry information

Official study title

Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Mar 21, 2013
Registry last updated: Oct 14, 2015

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.

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Completed