Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner

NCT ID: NCT00904956

Last Updated: 2011-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-12-31

Brief Summary

It is traditionally considered that someone with a positive tuberculin skin test (TST) (and/or positive result in Cell Interferon-Gamma Release Assay (TIGRA), depending on the different countries' guidelines) is infected but not ill when the absence of lesions is demonstrated in a thorax X-Ray assay. Even though, the experiences described in literature using cows and pigs as animal models for the study of LTBI demonstrate the presence of this kind of lesion in the animals, even too small to be detected by X-Ray assay, which would suggest they also could happen in human LTBI. Nowadays, the High Resolution Scanners (HR TC) offer the possibility of detecting any lesion approximately 1 mm in diameter, so the investigators plan to use this technique to screen people already infected by M. tuberculosis (but not ill, following the Diagnosis Standard Guidelines).

Additional pathological analysis of resected and post-mortem tissues will provide lesion-based profiles of humans infected with tuberculosis.

Detailed Description

It is traditionally considered that the development of 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. The investigators have developed a new original hypothesis based on scientific evidence that takes 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.

Conditions

Tuberculosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• People with TST+ (plus positive TIGRA result, if possible) and normal thorax X-ray assay (normal as absence of any detectable lesion)

Exclusion Criteria

• Active TB
• Any medical condition or illness that could compromise the volunteer's health if entering the project

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CIBERES CRP-TB program

UNKNOWN

Sponsor Role: collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fundació Institut Germans Trias i Pujol

Principal Investigators

Pere-Joan Cardona, MD, PhD

Role: STUDY_DIRECTOR

Fundació Institut Germans Trias i Pujol

Cristina Vilaplana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut Germans Trias i Pujol

Locations

Fundació Institut Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status: RECRUITING

Teknon Foundation

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Cristina Vilaplana, MD

Role: CONTACT

cvilaplana@gmail.com

+349344978681

Pere-Joan Cardona, MD, PhD

Role: CONTACT

pjcardona.igtp.germanstrias@gencat.cat

+349344978686

References

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.

Reference Type: BACKGROUND

PMID: 19308318 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19110471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17352686 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19407047 (View on PubMed)

Gil O, Diaz I, Vilaplana C, Tapia G, Diaz J, Fort M, Caceres N, Pinto S, Cayla J, Corner L, Domingo M, Cardona PJ. Granuloma encapsulation is a key factor for containing tuberculosis infection in minipigs. PLoS One. 2010 Apr 6;5(4):e10030. doi: 10.1371/journal.pone.0010030.

Reference Type: BACKGROUND

PMID: 20386605 (View on PubMed)

Cardona PJ. Revisiting the natural history of tuberculosis. The inclusion of constant reinfection, host tolerance, and damage-response frameworks leads to a better understanding of latent infection and its evolution towards active disease. Arch Immunol Ther Exp (Warsz). 2010 Feb;58(1):7-14. doi: 10.1007/s00005-009-0062-5. Epub 2010 Jan 5.

Reference Type: BACKGROUND

PMID: 20049645 (View on PubMed)

Other Identifiers

GRANLATHU

Identifier Type: -

Identifier Source: org_study_id