A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Tuberculosis

Intervention / Treatment
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* Drug: Interferon-Gamma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>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 | Drug: Interferon-Gamma<br>* received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein<br>* Other names: Interferon gamma human recombinant;|
| No Intervention<br>only basic anti-tuberculosis therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of abacillated patients | Proportion of abacillated patients according to fluorescence microscopy | 1 month | 
| Proportion of abacillated patients | Proportion of abacillated patients according to culture data | 1 month | 
| Proportion of abacillated patients | Proportion of abacillated patients according to fluorescence microscopy | 2 month | 
| Proportion of abacillated patients | Proportion of abacillated patients according to culture data | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who died | deaths associated with HIV infection and/or tuberculosis | 5 month | 
| Proportion of patients who required a change in therapy | Proportion of patients who required a change in therapy due to ineffectiveness | 5 month | 
| Proportion of patients with adverse reactions | Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance | 5 month | 
| Changes in the level of CD4 lymphocytes and HIV viral load in the blood | 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) | 5 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interferon gamma, Respiratory tuberculosis