Clinical trial NCT02897180: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Close Contacts of Active Tuberculosis
Keywords: tuberculosis
latent tuberculosis infection
Food supplement
Mycobacterium manresensis
Nyaditum resae
Efficacy trial
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
First posted: 2016-09-13
Enrollment: 3300
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy, incidence of confirmed cases of active TB
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy, incidence of all cases of active TB and mortality (all causes)
timeFrame: 2 years
measure: Incidence of adverse events during the administration of the NR
timeFrame: 2 weeks
Other outcomes:
measure: Time to active TB
timeFrame: 2 years
Locations:
city: Tbilisi
country: Georgia
facility: National Center for Tuberculosis and Lung Diseases
Study officials:
affiliation: Fundacio Institut Germans Trias i Pujol (IGTP)
name: Pere-Joan Cardona, MD, PhD, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.