Text Size

Volatile Organic Compounds in Cystic Fibrosis (VOCCF)

This study has been completed.
Sponsor:
Information provided by:
Landon Pediatric Foundation
ClinicalTrials.gov Identifier:
NCT01379040
First received: June 21, 2011
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

This experiment is designed to test the effectiveness of a new electronic nose device, which allows a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of bacterial organisms in the lower respiratory tract. It consists of:

  • A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.
  • Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.
  • Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.

This study will test the hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by patients with cystic fibrosis. This study will test the additional hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath from the patient providing the sputum.


Condition
Cystic Fibrosis
Pseudomonas Aeruginosa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Pulmonary Colonization in Cystic Fibrosis Patients

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Landon Pediatric Foundation:

Estimated Enrollment: 75
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cystic Fibrosis Patients
Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
Control
Healthy volunteers

  Eligibility

Ages Eligible for Study:   1 Year to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will be selected from Dr. Landon's primary care clinic.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Cystic Fibrosis
  • Must be able to give breath and sputum samples

Exclusion Criteria:

  • Heavy smoker
  • Inability to regularly give breath and sputum samples
  • History of additional pulmonary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379040

Locations
United States, California
Pediatric Diagnostic Center
Ventura, California, United States, 93003
Sponsors and Collaborators
Landon Pediatric Foundation
  More Information

No publications provided

Responsible Party: Dr. Chris Landon, Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT01379040     History of Changes
Other Study ID Numbers: CF1
Study First Received: June 21, 2011
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Landon Pediatric Foundation:
Cystic Fibrosis
Pseudomonas aeruginosa
Volatile Organic Compounds
Electronic nose
Gas Chromatography

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013