Status:
UNKNOWN
A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis
Lead Sponsor:
SPP Pharmaclon Ltd.
Conditions:
Respiratory Tuberculosis
Eligibility:
All Genders
18-78 years
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 rese...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06118619
Start Date
June 1 2022
End Date
March 1 2024
Last Update
November 9 2023
Active Locations (13)
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1
Astrakhan Oblast Tuberculosis Clinic
Astrakhan, Astrakhan Oblast, Russia, 414004
2
Tuberculosis Clinic of the Republic of Bashkortostan
Ufa, Bashkortostan Republic, Russia, 450080
3
Tuberculosis Clinic of the Chuvash Republic
Cheboksary, Chuvashskaya Respublika, Russia, 428015
4
Leningrad Oblast Tuberculosis Clinic
Slantsy, Leningradskaya Oblast', Russia, 188560