- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00904956
Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner (GRANLATHU)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cristina Vilaplana, MD
- Phone Number: +349344978681
- Email: cvilaplana@gmail.com
Study Contact Backup
- Name: Pere-Joan Cardona, MD, PhD
- Phone Number: +349344978686
- Email: pjcardona.igtp.germanstrias@gencat.cat
Study Locations
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-
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Barcelona, Spain
- Recruiting
- Teknon Foundation
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Principal Investigator:
- Manuel Escobar, MD, PhD
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Principal Investigator:
- Nadine Romera, MD
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Recruiting
- Hospital Universitari Germans Trias i Pujol
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Principal Investigator:
- Juan Ruiz-Manzano, MD
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Sub-Investigator:
- Irma Casas, MD
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Sub-Investigator:
- Maria Esteve, MD
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Principal Investigator:
- Gustavo Tapia, MD
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Badalona, Barcelona, Spain, 08916
- Recruiting
- Fundació Institut Germans Trias i Pujol
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Principal Investigator:
- Cristina Vilaplana, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRANLATHU
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