Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection (HYPDYN)
Recruitment status was Recruiting
It is traditionally considered that the development of Latent Tuberculosis Infection (LTBI) is due to the M. tuberculosis ability to develop a dormancy state within well-structured lesions (granulomas), which can remain in the lung of the host even for life. A new original hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific evidence that take into account the idea that a lesion cannot be held forever, because the host tends to remove any lesion in order to rebuild the original parenchyma, in a healing process. Even if M. tuberculosis can remain in a dormant/non-replicating state for a long period, this is an important but not sufficient factor to explain the LTBI. The Dynamic Hypothesis tries to explain the existence of LTBI in spite of the healing process that could remove it by a constant reinfection of the host's tissue. While the "Static" view defends the induction of active TB after the reactivation of the bacilli from and old lesion; while the "Dynamic" view wants to demonstrate that there is a constant induction of new granulomas. In case one of these new lesions takes place in the upper lobe privileged zone, the possibility to induce a cavity would appear, developing an active Tuberculosis (TB).
Latent Tuberculosis Infection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection|
- QuantiFeron-Gold-In Tube method assay [ Time Frame: Every 6 months during 3 years ] [ Designated as safety issue: No ]
- Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate [ Time Frame: Once every year (every 6 months if possible), during 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood collected on QuantiFeron-Gold-In Tube tubes. Exhaled breath collected on R-Tube
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Patients with LTBI recently diagnosed under prophylactic chemotherapy treatment.
Patients with LTBI recently diagnosed not following any prophylactic chemotherapy treatment.
Patients with LTBI diagnosed time ago.
Positive control for the Exhaled Breath condensate assay only. Patients with active TB will conform this group. The n of this group is determined, as it will only be used as a positive control to prove the bacilli's DNA can be detected in the exhaled breath condensate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905970
|Contact: Cristina Vilaplana, MDfirstname.lastname@example.org|
|Contact: Pere-Joan Cardona, MD, PhDemail@example.com|
|Fundació Institut Germans Trias i Pujol||Recruiting|
|Badalona, Barcelona, Spain, 08916|
|Sub-Investigator: Cristina Vilaplana, MD|
|Principal Investigator:||Pere-Joan Cardona, MD, PhD||Fundació Institut Germans Trias i Pujol|