Volatile Organic Compounds in Cystic Fibrosis (VOCCF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01379040|
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : August 13, 2014
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|
|Cystic Fibrosis Pseudomonas Aeruginosa||Other: Cystic Fibrosis patients|
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Detection of Pulmonary Colonization in Cystic Fibrosis Patients|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2010|
Cystic Fibrosis Patients
Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
Other: Cystic Fibrosis patients
- Bacterial Identification [ Time Frame: six months ]Patient's provided breath samples and sputum for culture. Bacterial identification by indices was achieved
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379040
|United States, California|
|Pediatric Diagnostic Center|
|Ventura, California, United States, 93003|