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Volatile Organic Compounds in Cystic Fibrosis (VOCCF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chris Landon, Landon Pediatric Foundation
ClinicalTrials.gov Identifier:
NCT01379040
First received: June 21, 2011
Last updated: August 12, 2014
Last verified: August 2014
  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 Intervention
Cystic Fibrosis
Pseudomonas Aeruginosa
Other: Cystic Fibrosis patients

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:


Further study details as provided by Landon Pediatric Foundation:

Primary Outcome Measures:
  • Bacterial Identification [ Time Frame: six months ] [ Designated as safety issue: No ]
    Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved


Enrollment: 24
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 Assigned Interventions
Cystic Fibrosis Patients
Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
Other: Cystic Fibrosis patients
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Chris Landon, Principal Investigator, Landon Pediatric Foundation
ClinicalTrials.gov Identifier: NCT01379040     History of Changes
Other Study ID Numbers: CF1
Study First Received: June 21, 2011
Last Updated: August 12, 2014
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
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014