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Cough-Generated Aerosols of NTM in Cystic Fibrosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01815866
Enrollment
5
Registered
2013-03-21
Start date
2013-04-30
Completion date
2015-07-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Positive Nontuberculous Mycobacteria

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.

Detailed description

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.

Interventions

PROCEDURECF 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.

Sponsors

Children's Miracle Network
CollaboratorOTHER
UF Peds
CollaboratorUNKNOWN
University of Florida
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of CF patients who produce culturable aerosols of NTM during coughing.6 weeksPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026