Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection

NCT00905970 | Unknown DMC

• 2 other identifiers: HYPDYNCEIC EO-07-033
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Latent Tuberculosis Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Latent Tuberculosis Infected people

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Fundació Institut Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 19308318 BACKGROUND

• 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.

  PMID: 19110471 BACKGROUND

• 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.

  PMID: 17352686 BACKGROUND

• 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.

  PMID: 19407047 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood collected on QuantiFeron-Gold-In Tube tubes. Exhaled breath collected on R-Tube

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Pere-Joan Cardona, MD, PhD

  Fundació Institut Germans Trias i Pujol

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Vilaplana, MD

CONTACT

+3493497861; cvilaplana@gmail.com

Pere-Joan Cardona, MD, PhD

CONTACT

+34934978686; pjcardona.igtp.germanstrias@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 11, 2011

Record last verified: 2009-11

Locations

ES (1)