Pulmonary Tuberculosis Clinical Trial
Official title:
An Open Prospective Observational Study Evaluating the Efficacy and Tolerability of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for intramuscular or subcutaneous administration of 500,000 IU.
Open prospective observational cohort study. During the recruitment phase, a preliminary assessment of eligibility and non-inclusion criteria will be carried out. Subject to prior compliance with all inclusion criteria and none of the exclusion criteria, after signing a voluntary informed consent, the patient will be included in the study. Patients will be divided into groups, depending on the therapy prescribed to them as part of routine clinical practice (according to clinical guidelines): Group 1: Pathogenetic therapy with the use of the drug Ingaron + basic anti-tuberculosis therapy in accordance with approved clinical guidelines. Group 2: Basic anti-tuberculosis therapy in accordance with approved clinical guidelines. When a patient is included in the study (Visit 0), an initial examination will be carried out, in accordance with generally accepted principles of treatment monitoring, which includes: history taking, physical examination, registration of vital signs, ECG, blood samples for general clinical, biochemical analysis, general analysis urine, bacteriological examination by sputum smear microscopy and sputum culture on dense nutrient media with drug sensitivity assessment, computed tomography and chest radiography. The inclusion/exclusion criteria will be checked. The expected duration of the study for each patient will be no more than 204 days. After the start of therapy, patients will be recorded monthly with physical examination data with registration of vital signs, general clinical, biochemical analyzes, urinalysis, smear microscopy and sputum culture. X-ray examination and clinical evaluation of effectiveness will be carried out every 2 months. At visit 7 (after 6 months from the start of therapy), an evaluation of computed tomography and chest x-ray in dynamics with an assessment of the effectiveness of therapy, as well as ECG, physical examination with registration of vital signs, general clinical, biochemical analyzes, general urinalysis, smear microscopy and culture of sputum. At visits 1, 4 and 7 immunological parameters will be assessed. ;
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