Clinical trial NCT00905970: Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
Official title: Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Latent Tuberculosis Infection
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2009-05-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Latent Tuberculosis Infected people

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* being at least 18 years old
* to be M.tuberculosis infected (diagnosed by a positive TST with or without a positive result in the QuantiFeron-TB-Gold In tube assay)

Exclusion Criteria:

* active TB
* individuals not willing to participate in the study and or not willing to sign the informed consent form
* individuals not able to decide their participation in the study

Primary outcomes:
measure: QuantiFeron-Gold-In Tube method assay
timeFrame: Every 6 months during 3 years
measure: Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate
timeFrame: Once every year (every 6 months if possible), during 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Fundació Institut Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: Fundació Institut Germans Trias i Pujol
name: Pere-Joan Cardona, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cardona PJ. A dynamic reinfection hypothesis of latent tuberculosis infection. Infection. 2009 Apr;37(2):80-6. doi: 10.1007/s15010-008-8087-y. Epub 2009 Mar 23.
citation: Caceres N, Tapia G, Ojanguren I, Altare F, Gil O, Pinto S, Vilaplana C, Cardona PJ. Evolution of foamy macrophages in the pulmonary granulomas of experimental tuberculosis models. Tuberculosis (Edinb). 2009 Mar;89(2):175-82. doi: 10.1016/j.tube.2008.11.001. Epub 2008 Dec 24.
citation: Cardona PJ. New insights on the nature of latent tuberculosis infection and its treatment. Inflamm Allergy Drug Targets. 2007 Mar;6(1):27-39. doi: 10.2174/187152807780077282.
citation: Mack U, Migliori GB, Sester M, Rieder HL, Ehlers S, Goletti D, Bossink A, Magdorf K, Holscher C, Kampmann B, Arend SM, Detjen A, Bothamley G, Zellweger JP, Milburn H, Diel R, Ravn P, Cobelens F, Cardona PJ, Kan B, Solovic I, Duarte R, Cirillo DM; C. Lange; TBNET. LTBI: latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement. Eur Respir J. 2009 May;33(5):956-73. doi: 10.1183/09031936.00120908.