Clinical trial NCT06118619: A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis
Official title: A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Tuberculosis
Keywords: Respiratory tuberculosis
interferon gamma
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with tuberculosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of abacillated patients
timeFrame: 1 month
measure: Proportion of abacillated patients
timeFrame: 1 month
measure: Proportion of abacillated patients
timeFrame: 2 month
measure: Proportion of abacillated patients
timeFrame: 2 month
Secondary outcomes:
measure: Proportion of patients who died
timeFrame: 5 month
measure: Proportion of patients who required a change in therapy
timeFrame: 5 month
measure: Proportion of patients with adverse reactions
timeFrame: 5 month
measure: Changes in the level of CD4 lymphocytes and HIV viral load in the blood
timeFrame: 5 month
Other outcomes:
Locations:
city: Astrakhan
country: Russian Federation
facility: Astrakhan Oblast Tuberculosis Clinic
state: Astrakhan Oblast
city: Cheboksary
country: Russian Federation
facility: Tuberculosis Clinic of the Chuvash Republic
state: Chuvash Republic
city: Slantsy
country: Russian Federation
facility: Leningrad Oblast Tuberculosis Clinic
state: Leningrad Oblast
city: Tikhvin
country: Russian Federation
facility: Leningrad Oblast Tuberculosis Hospital in Tikhvin
state: Leningrad Oblast
city: Perm
country: Russian Federation
facility: Clinical Phthisiopulmonological Medical Center
state: Perm Region
city: Ufa
country: Russian Federation
facility: Tuberculosis Clinic of the Republic of Bashkortostan
state: Republic Of Bashkortostan
city: Kazan
country: Russian Federation
facility: Republican Tuberculosis Clinic
state: Republic Of Tatarstan
city: Ryazan
country: Russian Federation
facility: Ryazan Oblast Tuberculosis Clinic
state: Ryazan Oblast
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases
state: Sverdlovsk Oblast
city: Volgograd
country: Russian Federation
facility: Volgograd Oblast Tuberculosis Clinic
state: Volgograd Oblast
city: Voronezh
country: Russian Federation
facility: N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary
state: Voronezh Oblast
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl regional tuberculosis clinic
state: Yaroslavl Region
city: Saint Petersburg
country: Russian Federation
facility: City tuberculosis clinic
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Anatoly I Saulin, Master
role: STUDY_DIRECTOR
References: