Pulmonary TuberculosisTBVOCNCT01379066
Tuberculosis Volatile Organic Compounds
An observational study of Pulmonary Tuberculosis, run by Landon Pediatric Foundation at 2 sites in United States.
Trial summary
The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. Read more about this study
- Who is it for?
- Ages 1 year to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Tuberculosis
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.
Who may be able to join
- Suspected tuberculosis infection or disease
- Positive tuberculosis skin test
- Positive sputum culture for TB
- X-rays indicated possible tuberculosis infection or disease
- ability to give breath and sputum samples at regular intervals
Who cannot join
- Heavy smoker
- History of or active pulmonary disease other than tuberculosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oxnard Specialty Clinic
Oxnard, California, 93033
Pediatric Diagnostic Center
Ventura, California, 93003
About this study
Official title: Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph
The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial 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.
- Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography.
Read more
This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses:
- that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification
- that the investigators can identify control of tuberculosis by sampling exhaled breath
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Mycobacterium tuberculosis, Pulmonary tuberculosis, Electronic nose, Gas chromatography
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tuberculosis Patients | Suspected Tuberculosis patients | |
| Control | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of tuberculosis from bacterial plates
Tuberculosis will be identified form culture plates by the volatile organic compound signature
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379066
- Sponsor's protocol ID
- TB1
- Acronym
- TBVOC
- Status last verified
- Aug 2014
- First submitted
- 21 Jun 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph
- ClinicalTrials.gov ID
- NCT01379066
- Acronym / sponsor ID
- TBVOC / TB1
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Mycobacterium tuberculosis, Pulmonary tuberculosis, Electronic nose, Gas chromatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial 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.
- Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography.
This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses:
- that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification
- that the investigators can identify control of tuberculosis by sampling exhaled breath
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuberculosis Patients | – | –Suspected Tuberculosis patients |
| Control | – | –Healthy volunteers |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Tuberculosis patients will be enrolled through the Tuberculosis Specialty Clinic in Oxnard, Ca.
Key inclusion criteria (5 listed)
- Suspected tuberculosis infection or disease
- Positive tuberculosis skin test
- Positive sputum culture for TB
- X-rays indicated possible tuberculosis infection or disease
- ability to give breath and sputum samples at regular intervals
Key exclusion criteria (2 listed)
- Heavy smoker
- History of or active pulmonary disease other than tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of tuberculosis from bacterial plates
Time frame: 6 months
Tuberculosis will be identified form culture plates by the volatile organic compound signature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
Related trials for Pulmonary Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
RecruitingPhase 2
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Pulmonary Tuberculosis
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis, run by Landon Pediatric Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of tuberculosis from bacterial plates (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.