A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis
NCT ID: NCT06118619
Last Updated: 2023-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2022-06-01
2024-03-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Experimental
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
Interferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
No Intervention
only basic anti-tuberculosis therapy
No interventions assigned to this group
Interventions
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Interferon-Gamma
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
78 Years
ALL
No
Sponsors
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SPP Pharmaclon Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Anatoly I Saulin, Master
Role: STUDY_DIRECTOR
SPP Pharmaclon Ltd.
Locations
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Astrakhan Oblast Tuberculosis Clinic
Astrakhan, Astrakhan Oblast, Russia
Tuberculosis Clinic of the Republic of Bashkortostan
Ufa, Bashkortostan Republic, Russia
Tuberculosis Clinic of the Chuvash Republic
Cheboksary, Chuvashskaya Respublika, Russia
Leningrad Oblast Tuberculosis Clinic
Slantsy, Leningradskaya Oblast', Russia
Leningrad Oblast Tuberculosis Hospital in Tikhvin
Tikhvin, Leningradskaya Oblast', Russia
Clinical Phthisiopulmonological Medical Center
Perm, Perm Krai, Russia
Ryazan Oblast Tuberculosis Clinic
Ryazan, Ryazan Oblast, Russia
Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Tuberculosis Clinic
Kazan', Tatarstan Republic, Russia
Volgograd Oblast Tuberculosis Clinic
Volgograd, Volgograd Oblast, Russia
N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary
Voronezh, Voronezh Oblast, Russia
Yaroslavl regional tuberculosis clinic
Yaroslavl, Yaroslavl Oblast, Russia
City tuberculosis clinic
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GAM2022
Identifier Type: -
Identifier Source: org_study_id
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