Volatile Organic Compounds in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pseudomonas Aeruginosa Pseudomonas Infections Respiratory Tract Diseases

Age range

1 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Diagnostic Center

Ventura, California, 93003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cystic Fibrosis patients

Other

Primary outcomes

Bacterial Identification

Time frame: six months

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

Sponsors and collaborators

Lead sponsor

Landon Pediatric Foundation

Other

Registry information

Official study title

Detection of Pulmonary Colonization in Cystic Fibrosis Patients

Acronym: VOCCF

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Jun 23, 2011
Registry last updated: Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed