Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection (HYPDYN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905970
Recruitment Status : Unknown
Verified November 2009 by Germans Trias i Pujol Hospital.
Recruitment status was:  Recruiting
First Posted : May 21, 2009
Last Update Posted : July 11, 2011
Fondo de Investigacion Sanitaria
Information provided by:
Germans Trias i Pujol Hospital

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
Latent Tuberculosis Infection

Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
Study Start Date : May 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. QuantiFeron-Gold-In Tube method assay [ Time Frame: Every 6 months during 3 years ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood collected on QuantiFeron-Gold-In Tube tubes. Exhaled breath collected on R-Tube

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Latent Tuberculosis Infected people

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00905970

Contact: Cristina Vilaplana, MD +3493497861
Contact: Pere-Joan Cardona, MD, PhD +34934978686

Fundació Institut Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Sub-Investigator: Cristina Vilaplana, MD         
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Fondo de Investigacion Sanitaria
Principal Investigator: Pere-Joan Cardona, MD, PhD Fundació Institut Germans Trias i Pujol

Responsible Party: Dr. Pere-Joan Cardona, Experimental Tuberculosis Unit. Fundació Institut Germans Trias i Pujol Identifier: NCT00905970     History of Changes
Other Study ID Numbers: HYPDYN
CEIC EO-07-033
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Communicable Diseases
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections