Status:
UNKNOWN
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
Lead Sponsor:
SPP Pharmaclon Ltd.
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-75 years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Men or non-pregnant women 18-75 years of age.
- For women of childbearing age who are fertile: Agree to completely abstain from sexual intercourse or use dual methods of contraception to prevent pregnancy while participating in the study.
- Verified diagnosis of pulmonary tuberculosis (infiltrative tuberculosis, fibrous-cavernous tuberculosis in the infiltration phase).
- A positive sputum smear microscopy test result for acid-fast bacterium, assessed as moderate (++) or massive bacterial excretion (+++) no earlier than 30 days prior to enrollment in the study.
- Established resistance of the isolated pathogen to at least rifampicin, determined by molecular genetic or cultural methods for determining drug susceptibility.
- Prescribing the current baseline chemotherapy regimen according to clinical guidelines no earlier than 14 days prior to enrollment in the study.
- Compliance with prescribed therapy.
- No concomitant immunotherapy, or 6 months from the last dose of an immunomodulatory drug to the start of therapy.
- Absence of comorbidities and therapy that may affect the interpretation of study results, in the opinion of the investigator.
- Signed written informed consent to participate in the study.
- Willingness and ability to follow protocol requirements throughout the study.
Exclusion
- For women: pregnant, breastfeeding or planning a pregnancy during the study period.
- Caseous pneumonia.
- Asthma, with the exception of mild intermittent asthma.
- Systemic fungal infections.
- Use of any investigational drug within 30 days prior to screening.
- Oncological diseases (cytotoxic chemotherapy, current or received within the last 3 months before the start of treatment).
- Chronic diseases of the liver or kidneys (an increase in liver transaminases more than 5 times the upper limit of laboratory norms for these indicators; an increase in creatinine above 2 mg / 100 ml (or μmol / l)).
- Diabetes.
- HIV infection or other immunodeficiency conditions.
- Inability, in the opinion of the investigator, to comply with the treatment regimen and the requirements of the study protocol.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05359315
Start Date
April 15 2022
End Date
May 1 2023
Last Update
June 1 2022
Active Locations (1)
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1
FSBI "NMIC FPI" of the Ministry of Health of Russia
Moscow, Russia, 127473