Intervention: Isoniazid
Trial phase: Phase 2
ATC code: J04AC01 | J04AC51 | J04AM01 | J04AM02 | J04AM03 | J04AM04 | J04AM05 | J04AM06 | J04AM07 | J04AM08
SMILES: NNC(=O)c1ccncc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 2 tablets 300 mg of Isoniazid once a day for 14 days

Isoniazid: Once a day for 14 days
Eligibility criteria:
Inclusion Criteria:

Written informed consent received from a volunteer
Men and women aged 18 to 65 years, inclusive
The first-diagnosed active pulmonary tuberculosis, confirmed by characteristic radiographic changes (infiltration, dissemination, destruction) during radiography or computed tomography of chest organs, without damage to other organs or with the defeat of one or more of the following organs: larynx, trachea, bronchi, lymph nodes
The amount of sputum given by the patient is sufficient for carrying out the analyzes provided for by the protocol, but not less than 4-5 ml at the screening
The presence of acid-fast mycobacteria in the sputum according to the results of microscopy of smears (1+ and more using the method of microscopy with luminescent dye staining according to the Order of the Ministry of Health of the Russian Federation of March 21, 2003 No. 109, the last edition) and the detection of the DNA of mycobacteria of tuberculosis by the results of molecular genetic methods of diagnosis
Body weight not less than 51 kg
Body mass index of 18.5-25 kg/m2
Ability, according to investigators opinion, to comply with all requirements of the protocol

Agreement to use double contraception method during the study participation and for 3 months after the test drug administration - combination of male condom with not less than one of the following methods:

female partner using hormonal contraception;
using aerosols, creams, suppositories and other agents containing spermicides;
female partner using intrauterine device

Exclusion Criteria:

Extrapulmonary localization of tuberculosis
Presence of resistance to rifampicin and / or isoniazid in the study of sputum samples using molecular genetic methods
Admission of any anti-tuberculosis drugs from the moment of diagnosis of tuberculosis to the moment of inclusion in the study
The presence of absolute indications for surgical treatment of tuberculosis at the time of screening
Positive tests for serological markers of syphilis or HIV infection during screening; active hepatitis or decompensated hepatic cirrhosis
Aggravated allergic history, including presence of at least one episode of drug allergy

The values of renal and / or hepatic parameters according to laboratory analyzes (taking into account the range of normal laboratory values):

Aspartate aminotransferase (AST) level > 2.0 x upper limit of the norm
Alanine aminotransferase (ALT) level > 2.0 x upper limit of norm
General bilirubin level > 1.5 x upper limit of norm
Creatinine level > 1.5 x upper limit of norm
Individual drug components intolerance
Presence in the anamnesis of malignant neoplasms, except for basal cell skin cancer
The presence of severe chronic somatic diseases in the stage of decompensation, including diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, ear, nose and throat (ENT) organs, the gastrointestinal tract, liver, kidneys, blood, skin, or any other somatic or mental diseases that, according to the researcher, prevent the patient from entering the study
Gastrointestinal surgeries (except for appendectomy performed not less than 1 year before screening)
Mental illness that may interfere with the patient's compliance with the protocol
Diabetes mellitus
Acute viral and bacterial infections at the time of enrollment or within 2 weeks before enrollment
Alcoholism (except in cases when the patient is able, in the opinion of the researcher, to refrain from taking alcohol during the period of participation in the study), drug addiction, abuse of medicines
Positive tests for narcotic and psychotropic agents
Regular admission or use (including externally) of any hormonal medicines lasting more than 1 week less than 30 days before screening (with the exception of oral hormonal contraceptives and intrauterine spirals containing hormones)
Use of cytostatic drugs less than 30 days before screening
Multiple admission of drugs with the described in the instructions for medical use adverse events related to nervous system, hemodynamic and hepatic functions with frequencies "very frequent" (≥10%) and "often" (≥1% and <10%) less than 21 days before screening
Pregnancy or lactation period
Planned conception or sperm donation during the study after the test drug administration or during 3 months after the last date of drug administration
Participation in other clinical studies of drugs within less than 3 months before the screening