A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

SPP Pharmaclon Ltd.350 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Respiratory Tuberculosis

Interventions

Interferon-GammaDRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (13)

Astrakhan Oblast Tuberculosis Clinic

Astrakhan, Astrakhan Oblast, Russia

RECRUITING

Tuberculosis Clinic of the Republic of Bashkortostan

Ufa, Bashkortostan Republic, Russia

Outcomes

Primary Outcomes

Proportion of abacillated patients

Proportion of abacillated patients according to fluorescence microscopy

Time frame: 1 month

Proportion of abacillated patients

Proportion of abacillated patients according to culture data

Time frame: 1 month

Proportion of abacillated patients

Proportion of abacillated patients according to fluorescence microscopy

Time frame: 2 month

Proportion of abacillated patients

Proportion of abacillated patients according to culture data

Time frame: 2 month

Secondary Outcomes

Proportion of patients who died

deaths associated with HIV infection and/or tuberculosis

Time frame: 5 month

Proportion of patients who required a change in therapy

Proportion of patients who required a change in therapy due to ineffectiveness

Time frame: 5 month

Proportion of patients with adverse reactions

Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance

Time frame: 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)

Central Contacts

Julia A Isakova, Master

CONTACT

8 107 905 535-33-11 isakova@pharmaclon.ru

Polina I Pekhtereva, Master

CONTACT

8 107 909 675-96-43 pekhtereva@pharmaclon.ru

Data from ClinicalTrials.gov

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