Respiratory Tuberculosis
Conditions
Keywords
Respiratory tuberculosis, interferon gamma
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.
Interventions
DRUGInterferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Sponsors
SPP Pharmaclon Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of abacillated patients | 1 month | Proportion of abacillated patients according to fluorescence microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who died | 5 month | deaths associated with HIV infection and/or tuberculosis |
| 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 |
| 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) |
Countries
Russia
Contacts
Primary ContactJulia A Isakova, Master
Backup ContactPolina I Pekhtereva, Master
Outcome results
None listed