Latent Tuberculosis InfectionHYPDYNNCT00905970
Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
An observational study of Latent Tuberculosis Infection, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
It is traditionally considered that the development of Latent Tuberculosis Infection (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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis Infection
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- May 2009to Dec 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Latent Tuberculosis Infected people
Who may be able to join
- being at least 18 years old
- to be M.tuberculosis infected (diagnosed by a positive TST with or without a positive result in the QuantiFeron-TB-Gold In tube assay)
Who cannot join
- active TB
- individuals not willing to participate in the study and or not willing to sign the informed consent form
- individuals not able to decide their participation in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundació Institut Germans Trias i Pujol
Badalona, Barcelona, 08916
Cristina Vilaplana, MD
About this study
It is traditionally considered that the development of Latent Tuberculosis Infection (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. A new original hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific evidence that take 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. While the "Static" view defends the induction of active TB after the reactivation of the bacilli from and old lesion; while the "Dynamic" view wants to demonstrate that there is a constant induction of new granulomas. In case one of these new lesions takes place in the upper lobe privileged zone, the possibility to induce a cavity would appear, developing an active Tuberculosis (TB).
- Conditions
- Latent Tuberculosis Infection
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with LTBI recently diagnosed under prophylactic chemotherapy treatment. | |
| 2 | Patients with LTBI recently diagnosed not following any prophylactic chemotherapy treatment. | |
| 3 | Patients with LTBI diagnosed time ago. | |
| 4 | Positive control for the Exhaled Breath condensate assay only. Patients with active TB will conform this group. The n of this group is determined, as it will only be used as a positive control to prove the bacilli's DNA can be detected in the exhaled breath condensate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuantiFeron-Gold-In Tube method assay
Measured: Every 6 months during 3 years
Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate
Measured: Once every year (every 6 months if possible), during 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Investigators
- Pere-Joan Cardona, MD, PhD, Principal investigator, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905970
- Sponsor's protocol ID
- HYPDYN
- Other IDs
- CEIC EO-07-033
- Acronym
- HYPDYN
- Status last verified
- Nov 2009
- First submitted
- 19 May 2009
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 19407047
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
- Demonstration of the Dynamic Hypothesis of Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT00905970
- Acronym / sponsor ID
- HYPDYN / HYPDYN
- Conditions
- Latent Tuberculosis Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria
- Study start
- May 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 21 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 the development of Latent Tuberculosis Infection (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. A new original hypothesis has been developed in the Experimental Tuberculosis Unit based on scientific evidence that take 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. While the "Static" view defends the induction of active TB after the reactivation of the bacilli from and old lesion; while the "Dynamic" view wants to demonstrate that there is a constant induction of new granulomas. In case one of these new lesions takes place in the upper lobe privileged zone, the possibility to induce a cavity would appear, developing an active Tuberculosis (TB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with LTBI recently diagnosed under prophylactic chemotherapy treatment. |
| 2 | – | –Patients with LTBI recently diagnosed not following any prophylactic chemotherapy treatment. |
| 3 | – | –Patients with LTBI diagnosed time ago. |
| 4 | – | –Positive control for the Exhaled Breath condensate assay only. Patients with active TB will conform this group. The n of this group is determined, as it will only be used as a positive control to prove the bacilli's DNA can be detected in the exhaled breath condensate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Latent Tuberculosis Infected people
Key inclusion criteria (2 listed)
- being at least 18 years old
- to be M.tuberculosis infected (diagnosed by a positive TST with or without a positive result in the QuantiFeron-TB-Gold In tube assay)
Key exclusion criteria (3 listed)
- active TB
- individuals not willing to participate in the study and or not willing to sign the informed consent form
- individuals not able to decide their participation in the study
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
QuantiFeron-Gold-In Tube method assay
Time frame: Every 6 months during 3 years
Detection of M.tuberculosis DNA and RNA in the exhaled breath condensate
Time frame: Once every year (every 6 months if possible), during 3 years
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.
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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 principal investigator
Fundació Institut Germans Trias i Pujol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis Infection, run by Germans Trias i Pujol Hospital at 1 site 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 2 inclusion and 3 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 1 site 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 (+3493497861, cvilaplana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuantiFeron-Gold-In Tube method assay (time frame: Every 6 months during 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00905970, which also lists 4 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.