A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

Recruiting

Brief Summary: The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.

Detailed Description: Monitoring of a patient in a hospital is carried out daily by the attending physician during the entire period of the patient's stay at the research center. When prescribing the drug Ingaron, the researcher must follow the instructions for use of the drug. As part of 4 control observations to assess effectiveness and safety:

* 1st on the 1st day of using the drug Ingaron and starting anti-tuberculosis therapy

* 2nd on the 30th - 31st day of therapy

* 3rd after 2 months of therapy

* 4th (final) after 3 months of follow-up After each of the 3 visits, the research doctor saves the data necessary for further evaluation.

Recruitment & Eligibility

Inclusion Criteria

Age from 18 to 78 years inclusive
Bacterioscopically and/or molecularly genetically verified diagnosis of tuberculosis
Stay in the intensive phase of treatment
Consent to inpatient anti-tuberculosis therapy until the end of participation in clinical observation

Exclusion Criteria

Serious condition
Pregnancy
Breastfeeding
Treatment with immunomodulatory drugs before inclusion in the observation program
Presence of medical history of an allergic reaction or individual intolerance to the drug Ingaron
Severe diseases of the liver, kidneys (creatinine more than 150 mmol/l)
Presence of contraindications to the administration of the drug Ingaron
Patients with HIV infection with a CD4 lymphocyte count less than 350 cells/ml

Arm && Interventions

Group	Intervention	Description
Experimental	Interferon-Gamma	Ingaron 500,000 IU intramuscularly 1 time per day daily or every other day for 2 months (60 days) - a total of 30 or 60 injections + basic anti-tuberculosis therapy

Primary Outcome Measures

Name	Time	Method
Proportion of abacillated patients	2 month	Proportion of abacillated patients according to culture data

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who died	5 month	deaths associated with HIV infection and/or tuberculosis
Changes in the level of CD4 lymphocytes and HIV viral load in the blood	5 month	Changes in the level of CD4 lymphocytes and HIV viral load in the blood (Proportion of patients with a CD4 level less than 350 cells/ml)
Proportion of patients who required a change in therapy	5 month	Proportion of patients who required a change in therapy due to ineffectiveness
Proportion of patients with adverse reactions	5 month	Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance

Locations (13): Tuberculosis Clinic of the Chuvash Republic
🇷🇺
Cheboksary, Chuvash Republic, Russian Federation
Clinical Phthisiopulmonological Medical Center
🇷🇺
Perm, Perm Region, Russian Federation
Leningrad Oblast Tuberculosis Clinic
🇷🇺
Slantsy, Leningrad Oblast, Russian Federation
Leningrad Oblast Tuberculosis Hospital in Tikhvin
🇷🇺
Tikhvin, Leningrad Oblast, Russian Federation
Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases
🇷🇺
Yekaterinburg, Sverdlovsk Oblast, Russian Federation
Astrakhan Oblast Tuberculosis Clinic
🇷🇺
Astrakhan, Astrakhan Oblast, Russian Federation
Ryazan Oblast Tuberculosis Clinic
🇷🇺
Ryazan, Ryazan Oblast, Russian Federation
Republican Tuberculosis Clinic
🇷🇺
Kazan, Republic Of Tatarstan, Russian Federation
Volgograd Oblast Tuberculosis Clinic
🇷🇺
Volgograd, Volgograd Oblast, Russian Federation
Tuberculosis Clinic of the Republic of Bashkortostan
🇷🇺
Ufa, Republic Of Bashkortostan, Russian Federation
N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary
🇷🇺
Voronezh, Voronezh Oblast, Russian Federation
Yaroslavl regional tuberculosis clinic
🇷🇺
Yaroslavl, Yaroslavl Region, Russian Federation
City tuberculosis clinic
🇷🇺
Saint Petersburg, Russian Federation