Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection

Latent Tuberculosis Infection Clinical Trial

— HYPDYN  

Official title:

Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00905970
• Other study ID #: HYPDYN
• Secondary ID: CEIC EO-07-033
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2009
• Last updated: July 8, 2011
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2009
• Source: Germans Trias i Pujol Hospital
• Contact: Cristina Vilaplana, MD
• Phone: +3493497861
• Email: cvilaplana[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Locations

Country	Name	City	State
Spain	Fundació Institut Germans Trias i Pujol	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Cáceres 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. — View 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. Review. — View 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. Review. — View Citation

Mack U, Migliori GB, Sester M, Rieder HL, Ehlers S, Goletti D, Bossink A, Magdorf K, Hölscher 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QuantiFeron-Gold-In Tube method assay		Every 6 months during 3 years	No
Primary	Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate		Once every year (every 6 months if possible), during 3 years	No

External Links

•   official website of the non-profit organisation of which the Experimental Tuberculosis Unit belongs as research unit