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

September 3, 2017 updated by: Fundació Institut Germans Trias i Pujol

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • National Center for Tuberculosis and Lung Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects will receive a total of 14 capsules with Placebo
Biological: Placebo
Capsules containin Placebo
Experimental: Nyaditum resae(R)
Subjects will receive a total of 14 capsules with Nyaditum resae(R)
Biological: Nyaditum resae(R)
Capsules containing Nyaditum resae(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy, incidence of all cases of active TB and mortality (all causes)
Time Frame: 2 years

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.
2 years
Incidence of adverse events during the administration of the NR
Time Frame: 2 weeks
Number of adverse events in both arms
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to active TB
Time Frame: 2 years
Number of days to develop active TB
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

Investigators

  • Principal Investigator: Pere-Joan Cardona, MD, PhD, Pr, Fundació Institut Germans Trias i Pujol (IGTP)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 3, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYADAGEORG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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