VOCCF: Volatile Organic Compounds in Cystic Fibrosis

• Sponsor: Landon Pediatric Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01379040
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Pseudomonas Aeruginosa	Other: Cystic Fibrosis patients

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection of Pulmonary Colonization in Cystic Fibrosis Patients
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Cystic Fibrosis Patients Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.	Other: Cystic Fibrosis patients
Control Healthy volunteers

Outcome Measures

Primary Outcome Measures

1. Bacterial Identification [six months]

   Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Diagnostic Center	Ventura	California	United States	93003

Sponsors and Collaborators

• Landon Pediatric Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chris Landon, Principal Investigator, Landon Pediatric Foundation
• ClinicalTrials.gov Identifier: NCT01379040
• Other Study ID Numbers: CF1
• First Posted: Jun 23, 2011
• Last Update Posted: Aug 13, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Chris Landon, Principal Investigator, Landon Pediatric Foundation: Cystic Fibrosis; Pseudomonas aeruginosa; Volatile Organic Compounds; Electronic nose; Gas Chromatography
• Additional relevant MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of Aug 13, 2014