HYPDYN: Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with LTBI recently diagnosed under prophylactic chemotherapy treatment. |
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| 2 Patients with LTBI recently diagnosed not following any prophylactic chemotherapy treatment. |
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| 3 Patients with LTBI diagnosed time ago. |
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| 4 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. |
Outcome Measures
Primary Outcome Measures
- QuantiFeron-Gold-In Tube method assay [Every 6 months during 3 years]
- Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate [Once every year (every 6 months if possible), during 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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being at least 18 years old
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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:
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active TB
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individuals not willing to participate in the study and or not willing to sign the informed consent form
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individuals not able to decide their participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fundació Institut Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
Sponsors and Collaborators
- Germans Trias i Pujol Hospital
- Fondo de Investigacion Sanitaria
Investigators
- Principal Investigator: Pere-Joan Cardona, MD, PhD, Fundació Institut Germans Trias i Pujol
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- HYPDYN
- CEIC EO-07-033