Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT01379066
Brief 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. 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:
NCT01379066
Study Brief:
Protocol Section:
NCT01379066