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

NCT02897180 | Unknown Phase 2 DMC

• 1 other identifier: NYADAGEORG
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Close Contacts of Active Tuberculosis

Keywords

tuberculosis; latent tuberculosis infection; Food supplement; Mycobacterium manresensis; Nyaditum resae; Efficacy trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Efficacy, incidence of all cases of active TB and mortality (all causes)

  2 years

• Incidence of adverse events during the administration of the NR

  2 weeks

Other Outcomes (1)

• Time to active TB

  2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive a total of 14 capsules with Placebo

Biological: Placebo

Nyaditum resae(R)

EXPERIMENTAL

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

Biological: Nyaditum resae(R)

Interventions

Nyaditum resae(R) BIOLOGICAL

Capsules containing Nyaditum resae(R)

Nyaditum resae(R)

Placebo BIOLOGICAL

Capsules containin Placebo

Placebo

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead
• National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia: collaborator

Study Sites (1)

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

RECRUITING

Related Publications (2)

• 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.

  PMID: 26779140 BACKGROUND

• 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.

  PMID: 28043488 DERIVED

Related Links

• Manremyc is the company that produces Nyaditum resae
• Experimental Tuberculosis Unit of the Germans Trias i Pujol website (PI's affiliation)
• National Center for Tuberculosis and Lung Diseases (NCTLD) in Tbilisi, Georgia.

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Pere-Joan Cardona, MD, PhD, Pr

  Fundacio Institut Germans Trias i Pujol (IGTP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pere-Joan Cardona, MD, PhD, Pr

CONTACT

+34934978686; pj.cardona@igtp.cat

Cris Vilaplana, MD, PhD

CONTACT

+34934978677; cvilaplana@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 13, 2016
• Study Start: March 10, 2017
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2021
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

GE (1)