A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

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