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

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:
CIBERES CRP-TB program
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00904956
First received: May 18, 2009
Last updated: July 8, 2011
Last verified: November 2009
  Purpose

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.


Condition
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner

Resource links provided by NLM:


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

Estimated Enrollment: 12
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Only a single population is going to be studied: the LTBI, thus people with proof to be M. tuberculosis infected but demonstrating not having active disease.

As the first approach to demonstrate the Dynamic Hypothesis in humans, up to 6 people will be included as controls.

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
  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: NCT00904956

Contacts
Contact: Cristina Vilaplana, MD +349344978681 cvilaplana@gmail.com
Contact: Pere-Joan Cardona, MD, PhD +349344978686 pjcardona.igtp.germanstrias@gencat.cat

Locations
Spain
Fundació Institut Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Principal Investigator: Cristina Vilaplana, MD         
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Principal Investigator: Juan Ruiz-Manzano, MD         
Sub-Investigator: Irma Casas, MD         
Sub-Investigator: Maria Esteve, MD         
Principal Investigator: Gustavo Tapia, MD         
Teknon Foundation Recruiting
Barcelona, Spain
Principal Investigator: Manuel Escobar, MD, PhD         
Principal Investigator: Nadine Romera, MD         
Sponsors and Collaborators
Germans Trias i Pujol Hospital
CIBERES CRP-TB program
Investigators
Study Director: Pere-Joan Cardona, MD, PhD Fundació Institut Germans Trias i Pujol
Principal Investigator: Cristina Vilaplana, MD, PhD Fundació Institut Germans Trias i Pujol
  More Information

Additional Information:
Publications:

Responsible Party: Pere-Joan Cardona, Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT00904956     History of Changes
Other Study ID Numbers: GRANLATHU
Study First Received: May 18, 2009
Last Updated: July 8, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Germans Trias i Pujol Hospital:
Latent Tuberculosis Infection
High Resolution Scanners
Dynamic Hypothesis of Latent Tuberculosis Infection

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

ClinicalTrials.gov processed this record on September 16, 2014