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| Name | Class |
|---|---|
| National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia | OTHER |
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The use of a supplement food like "Nyaditum resae" is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance.
In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.
Evaluation of a supplement food "Nyaditum resae" in the uincidence of TB. This is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in TB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will receive a total of 14 capsules with Placebo |
|
| Nyaditum resae(R) | Experimental | Subjects will receive a total of 14 capsules with Nyaditum resae(R) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nyaditum resae(R) | Biological | Capsules containing Nyaditum resae(R) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, incidence of confirmed cases of active TB | The primary endpoint is to assess the incidence of active TB: confirmed TB cases (including extrapulmonary TB) as described as: Clinical, radiology or histology evidence compatible with active TB plus validated Molecular Biology tests POSITIVE, or culture POSITIVE. The GeneXpert MTB/RIF system will be used as molecular diagnostic test to identify M. tuberculosis in this trial. Although this, in case a patient is diagnosed using any other validated method (i.e.: diagnosed in a site not participating in the trial), this could be accepted if well documented Cultures will be done using validated methodologies, including both solid and liquid cultures. An independent Endpoint Committee will be created to confirm all the TB cases. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy, incidence of all cases of active TB and mortality (all causes) | 1. Incidence of all TB: suspected and clinical active TB, defined as: • Suspected active TB: Do not meet the confirmed criteria but have compatible Clinical or Radiological or Pathological examinations AND supportive Microbiology (AFB positive) or non-validated Molecular Biology positive evaluations. • Clinical active TB: In the data collected, physician starts treatment without any supporting evidence of suspected or confirmed TB. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to active TB | Number of days to develop active TB | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pere-Joan Cardona, MD, PhD, Pr | Contact | +34934978686 | pj.cardona@igtp.cat | |
| Cris Vilaplana, MD, PhD | Contact | +34934978677 | cvilaplana@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pere-Joan Cardona, MD, PhD, Pr | Fundacio Institut Germans Trias i Pujol (IGTP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for Tuberculosis and Lung Diseases | Recruiting | Tbilisi | Georgia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26779140 | Background | Cardona P, Marzo-Escartin E, Tapia G, Diaz J, Garcia V, Varela I, Vilaplana C, Cardona PJ. Oral Administration of Heat-Killed Mycobacterium manresensis Delays Progression toward Active Tuberculosis in C3HeB/FeJ Mice. Front Microbiol. 2016 Jan 5;6:1482. doi: 10.3389/fmicb.2015.01482. eCollection 2015. | |
| 28043488 | Derived |
| Label | URL |
|---|---|
| Manremyc is the company that produces Nyaditum resae | View source |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Placebo |
| Biological |
Capsules containin Placebo |
|
| 2 years |
| Incidence of adverse events during the administration of the NR | Number of adverse events in both arms | 2 weeks |
| Tukvadze N, Cardona P, Vashakidze S, Shubladze N, Avaliani Z, Vilaplana C, Cardona PJ. Development of the food supplement Nyaditum resae as a new tool to reduce the risk of tuberculosis development. Int J Mycobacteriol. 2016 Dec;5 Suppl 1(Suppl 1):S101-S102. doi: 10.1016/j.ijmyco.2016.09.073. Epub 2016 Nov 14. |
| Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation) | View source |
| National Center for Tuberculosis and Lung Diseases (NCTLD) in Tbilisi, Georgia. | View source |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |