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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Germans Trias i Pujol Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00905970
First received: May 19, 2009
Last updated: July 8, 2011
Last verified: November 2009
  Purpose

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
Latent Tuberculosis Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 105
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)
Groups/Cohorts
1
Patients with LTBI recently diagnosed under prophylactic chemotherapy treatment.
2
Patients with LTBI recently diagnosed not following any prophylactic chemotherapy treatment.
3
Patients with LTBI diagnosed time ago.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Latent Tuberculosis Infected people

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905970

Contacts
Contact: Cristina Vilaplana, MD +3493497861 cvilaplana@gmail.com
Contact: Pere-Joan Cardona, MD, PhD +34934978686 pjcardona.igtp.germanstrias@gencat.cat

Locations
Spain
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
Investigators
Principal Investigator: Pere-Joan Cardona, MD, PhD Fundació Institut Germans Trias i Pujol
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Pere-Joan Cardona, Experimental Tuberculosis Unit. Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT00905970     History of Changes
Other Study ID Numbers: HYPDYN, CEIC EO-07-033
Study First Received: May 19, 2009
Last Updated: July 8, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on July 24, 2014