Close Contacts of Active TuberculosisPhase 2/3NCT02897180
Efficacy of Nyaditum Resae(R) Against Active TB in Georgia
A Phase 2/3 study testing Nyaditum resae(R) in people with Close Contacts of Active Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 1 site in Georgia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Close Contacts of Active Tuberculosis
- What is being tested?
- Nyaditum resae(R)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,300 participants
- Where
- 1 siteGeorgia
- Study dates
- 10 Mar 2017to Mar 2021
- Phase
- Phase 2/3
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have completed the written informed consent process prior to undergoing any screening evaluations.
- Have ability to complete follow-up period as required by the protocol.
- Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
- Close contact of an active TB case not eligible for chemoprophylaxis.
Who cannot join
- Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
- Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine.
- Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)
- Pregnancy or lactation
- Hypersensitivity to mannitol
- Suffering active TB
Trial locations and contacts
1 site in 1 country.
Georgia1 site, 1 recruiting
- Recruiting
National Center for Tuberculosis and Lung Diseases
Tbilisi
Nestani Tukvadze, MD, marikushane@yahoo.com
About this study
Official title: Double-blind, Randomized, Masked, Placebo-controlled, Clinical Trial to Investigate the Efficacy of the Nutraceutical Nyaditum Resae(R) Administered to Contacts of Active Tuberculosis in Georgia.
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.
Read the detailed description
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.
- Conditions
- Close Contacts of Active Tuberculosis
- Being tested
- Nyaditum resae(R), Placebo
- Keywords
- tuberculosis, latent tuberculosis infection, Food supplement, Mycobacterium manresensis, Nyaditum resae, Efficacy trial
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nyaditum resae(R)Biological
Capsules containing Nyaditum resae(R)
PlaceboBiological
Capsules containin Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive a total of 14 capsules with Placebo Receives: Biological: Placebo |
| Nyaditum resae(R) | Experimental | Subjects will receive a total of 14 capsules with Nyaditum resae(R) Receives: Biological: Nyaditum resae(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Efficacy, incidence of all cases of active TB and mortality (all causes)
- 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.
Measured: 2 years
Incidence of adverse events during the administration of the NR
Number of adverse events in both arms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start10 Mar 2017
- Primary completionOct 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Close Contacts of Active 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
- Responsible party
- Sponsor
- Investigators
- Pere-Joan Cardona, MD, PhD, Pr, Principal investigator, Fundacio Institut Germans Trias i Pujol (IGTP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897180
- Sponsor's protocol ID
- NYADAGEORG
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26779140Tukvadze 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.
PubMed 28043488
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Masked, Placebo-controlled, Clinical Trial to Investigate the Efficacy of the Nutraceutical Nyaditum Resae(R) Administered to Contacts of Active Tuberculosis in Georgia.
- ClinicalTrials.gov ID
- NCT02897180
- Acronym / sponsor ID
- NYADAGEORG
- Conditions
- Close Contacts of Active Tuberculosis
- Keywords
- tuberculosis, latent tuberculosis infection, Food supplement, Mycobacterium manresensis, Nyaditum resae, Efficacy trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Sep 2016 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboSubjects will receive a total of 14 capsules with Placebo |
| Nyaditum resae(R) | Experimental | Biological: Nyaditum resae(R)Subjects will receive a total of 14 capsules with Nyaditum resae(R) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have completed the written informed consent process prior to undergoing any screening evaluations.
- Have ability to complete follow-up period as required by the protocol.
- Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
- Close contact of an active TB case not eligible for chemoprophylaxis.
Key exclusion criteria (6 listed)
- Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
- Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine.
- Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)
- Pregnancy or lactation
- Hypersensitivity to mannitol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nyaditum resae(R)Capsules containing Nyaditum resae(R) | Biological | Nyaditum resae(R) |
| PlaceboCapsules containin Placebo | Biological | Placebo |
Primary outcome
Efficacy, incidence of confirmed cases of active TB
Time frame: 2 years
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 secondary outcomes
Efficacy, incidence of all cases of active TB and mortality (all causes)
Time frame: 2 years
Incidence of adverse events during the administration of the NR
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Background: PubMed 26779140Cardona 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.
- Derived from this study: PubMed 28043488Tukvadze 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.
- Manremyc is the company that produces Nyaditum resaeLink provided by the sponsor.
- Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation)Link provided by the sponsor.
- National Center for Tuberculosis and Lung Diseases (NCTLD) in Tbilisi, Georgia.Link provided by the sponsor.
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, Pr principal investigator
Fundacio Institut Germans Trias i Pujol (IGTP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nyaditum resae(R) in people with Close Contacts of Active Tuberculosis, run by Fundació Institut Germans Trias i Pujol at 1 site in Georgia.
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 4 inclusion and 6 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 7 Sep 2017. 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 Georgia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Pere-Joan Cardona, MD, PhD, Pr (+34934978686, pj.cardona@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy, incidence of confirmed cases of active TB (time frame: 2 years). 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 NCT02897180, which also lists 2 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 7 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.