Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner (GRANLATHU)
Recruitment status was Recruiting
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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 |
| 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) |
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 |
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.
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| Contact: Cristina Vilaplana, MD | +349344978681 | cvilaplana@gmail.com |
| Contact: Pere-Joan Cardona, MD, PhD | +349344978686 | pjcardona.igtp.germanstrias@gencat.cat |
| 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 | |
| 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 Latent Tuberculosis Mycobacterium Infections |
Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013