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Efficacy of Nyaditum Resae(R) Against Active TB in Georgia

Primary Purpose

Close Contacts of Active Tuberculosis

Status
Unknown status
Phase
Phase 2
Locations
Georgia
Study Type
Interventional
Intervention
Nyaditum resae(R)
Placebo
Sponsored by
Fundació Institut Germans Trias i Pujol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Close Contacts of Active Tuberculosis focused on measuring tuberculosis, latent tuberculosis infection, Food supplement, Mycobacterium manresensis, Nyaditum resae, Efficacy trial

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Have completed the written informed consent process prior to undergoing any screening evaluations.
  2. Have ability to complete follow-up period as required by the protocol.
  3. Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider.
  4. Close contact of an active TB case not eligible for chemoprophylaxis.

Exclusion Criteria:

  1. Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
  2. 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.
  3. Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)
  4. Pregnancy or lactation
  5. Hypersensitivity to mannitol
  6. Suffering active TB

Sites / Locations

  • National Center for Tuberculosis and Lung DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Nyaditum resae(R)

Arm Description

Subjects will receive a total of 14 capsules with Placebo

Subjects will receive a total of 14 capsules with Nyaditum resae(R)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of adverse events during the administration of the NR
Number of adverse events in both arms

Full Information

First Posted
September 7, 2016
Last Updated
September 3, 2017
Sponsor
Fundació Institut Germans Trias i Pujol
Collaborators
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
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1. Study Identification

Unique Protocol Identification Number
NCT02897180
Brief Title
Efficacy of Nyaditum Resae(R) Against Active TB in Georgia
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut Germans Trias i Pujol
Collaborators
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Close Contacts of Active Tuberculosis
Keywords
tuberculosis, latent tuberculosis infection, Food supplement, Mycobacterium manresensis, Nyaditum resae, Efficacy trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a total of 14 capsules with Placebo
Arm Title
Nyaditum resae(R)
Arm Type
Experimental
Arm Description
Subjects will receive a total of 14 capsules with Nyaditum resae(R)
Intervention Type
Biological
Intervention Name(s)
Nyaditum resae(R)
Intervention Description
Capsules containing Nyaditum resae(R)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Capsules containin Placebo
Primary Outcome Measure Information:
Title
Efficacy, incidence of confirmed cases of active TB
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Efficacy, incidence of all cases of active TB and mortality (all causes)
Description
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.
Time Frame
2 years
Title
Incidence of adverse events during the administration of the NR
Description
Number of adverse events in both arms
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Time to active TB
Description
Number of days to develop active TB
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere-Joan Cardona, MD, PhD, Pr
Phone
+34934978686
Email
pj.cardona@igtp.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Cris Vilaplana, MD, PhD
Phone
+34934978677
Email
cvilaplana@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere-Joan Cardona, MD, PhD, Pr
Organizational Affiliation
Fundacio Institut Germans Trias i Pujol (IGTP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Tuberculosis and Lung Diseases
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nestani Tukvadze, MD
Email
marikushane@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26779140
Citation
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.
Results Reference
background
PubMed Identifier
28043488
Citation
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.
Results Reference
derived
Links:
URL
http://www.manremyc.cat
Description
Manremyc is the company that produces Nyaditum resae
URL
http://unitatdetuberculosiexperimental.wordpress.com
Description
Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation)

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Efficacy of Nyaditum Resae(R) Against Active TB in Georgia

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