TuberculosisGRANLATHUNCT00904956
Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner
An observational study of Tuberculosis, run by Germans Trias i Pujol Hospital at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- How many people
- 12 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- People with TST+ (plus positive TIGRA result, if possible) and normal thorax X-ray assay (normal as absence of any detectable lesion)
Who cannot join
- Active TB
- Any medical condition or illness that could compromise the volunteer's health if entering the project
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Fundació Institut Germans Trias i Pujol
Badalona, Barcelona, 08916
Cristina Vilaplana, MD
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Juan Ruiz-Manzano, MD
Irma Casas, MD
- Recruiting
Teknon Foundation
Barcelona
Manuel Escobar, MD, PhD
Nadine Romera, MD
About this study
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.
Read the 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
- Keywords
- Latent Tuberculosis Infection, High Resolution Scanners, Dynamic Hypothesis of Latent Tuberculosis Infection
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CIBERES CRP-TB program
- Investigators
- Pere-Joan Cardona, MD, PhD, Study director, Fundació Institut Germans Trias i PujolCristina Vilaplana, MD, PhD, Principal investigator, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904956
- Sponsor's protocol ID
- GRANLATHU
- Acronym
- GRANLATHU
- Status last verified
- Nov 2009
- First submitted
- 18 May 2009
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19308318Caceres 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.
PubMed 19110471Cardona 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.
PubMed 17352686Mack 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.
PubMed 19407047Gil 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.
PubMed 20386605Cardona 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.
PubMed 20049645
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Latent Tuberculosis Infection (LTBI) by High Resolution Scanner
- ClinicalTrials.gov ID
- NCT00904956
- Acronym / sponsor ID
- GRANLATHU / GRANLATHU
- Conditions
- Tuberculosis
- Keywords
- Latent Tuberculosis Infection, High Resolution Scanners, Dynamic Hypothesis of Latent Tuberculosis Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- CIBERES CRP-TB program
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- People with TST+ (plus positive TIGRA result, if possible) and normal thorax X-ray assay (normal as absence of any detectable lesion)
Key exclusion criteria (2 listed)
- Active TB
- Any medical condition or illness that could compromise the volunteer's health if entering the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Background: PubMed 19308318Cardona 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.
- Background: PubMed 19110471Caceres 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.
- Background: PubMed 17352686Cardona 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.
- Background: PubMed 19407047Mack 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.
- Background: PubMed 20386605Gil 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.
- Background: PubMed 20049645Cardona 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere-Joan Cardona, MD, PhD study director
Fundació Institut Germans Trias i Pujol
Cristina Vilaplana, MD, PhD principal investigator
Fundació Institut Germans Trias i Pujol
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Germans Trias i Pujol Hospital at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Vilaplana, MD (+349344978681, cvilaplana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904956, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.