- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379040
Volatile Organic Compounds in Cystic Fibrosis (VOCCF)
Detection of Pulmonary Colonization in Cystic Fibrosis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Ventura, California, United States, 93003
- Pediatric Diagnostic Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
Healthy volunteers
|
|
Cystic Fibrosis Patients
Patients with Cystic Fibrosis, some having Pseudomonas aeruginosa, some not.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bacterial Identification
Time Frame: six months
|
Patient's provided breath samples and sputum for culture.
Bacterial identification by indices was achieved
|
six months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- http://www.beehive.co.jp/est/samplePDF/CysticFibrosis.pdf
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Pancreatic Diseases
- Fibrosis
- Cystic Fibrosis
- Pseudomonas Infections
Other Study ID Numbers
- CF1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on Cystic Fibrosis patients
-
University Hospital, GhentCompleted
-
Çağtay MadenCompletedCystic Fibrosis | Pulmonary Function | Muscle Strength | Functional Capacity | Exercise Tolerance | Muscular EnduranceTurkey
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic FibrosisUnited States
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
St. Paul's Hospital, CanadaCompleted
-
University Hospital, BordeauxCompletedCystic FibrosisFrance
-
Washington University School of MedicineCystic Fibrosis FoundationCompletedCystic FibrosisUnited States
-
Assistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseCompletedBack Pain | Chest Pain | Neck Pain | Cystic FibrosisFrance
-
Matthew GalskyAstraZenecaActive, not recruitingUrothelial CarcinomaUnited States
-
University of ReginaProvincial Health Services Authority; Saskatchewan Health Authority - Regina...RecruitingCystic Fibrosis | Mental Health | Siblings | Internet-based InterventionCanada