An observational study in Pulmonary Tuberculosis, sponsored by SPP Pharmaclon Ltd.. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by SPP Pharmaclon Ltd. · Observational
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 84 is below the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →SPP Pharmaclon Ltd. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with drug-resistant pulmonary tuberculosis with bacterial excretion
Exclusion Criteria:
Ingaron + basic TB therapy 500,000 IU once daily for 3 months followed by 3 months follow-up
Drug: Interferon-Gamma
only basic anti-tuberculosis therapy
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Also known as: Ingaron, Interferon gamma human recombinant
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 1 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 1 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 2 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 2 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 3 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 3 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 4 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 4 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 5 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 5 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Time frame: 6 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Time frame: 6 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 1 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 1 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 2 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 2 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 3 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 3 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 4 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 4 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 5 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 5 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Time frame: 6 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Time frame: 6 months
The effectiveness of therapy according to X-ray examination of the chest.
The effectiveness of therapy according to X-ray examination of the chest. Percentage of patients.
Time frame: 2 months
The effectiveness of therapy according to X-ray examination of the chest.
The effectiveness of therapy according to X-ray examination of the chest. Percentage of patients.
Time frame: 4 months
The effectiveness of therapy according to X-ray examination of the chest.
The effectiveness of therapy according to X-ray examination of the chest. Percentage of patients.
Time frame: 6 months
The effectiveness of therapy according to computed tomography of the chest.
The effectiveness of therapy according to computed tomography of the chest. Percentage of patients.
Time frame: 6 months
The effectiveness of therapy according to clinical examination.
The effectiveness of therapy according to clinical examination. Average score. The dynamics of clinical symptoms will be determined based on an assessment of the severity of intoxication (general) symptoms and respiratory complaints according to a 4-point system, where the minimum score is 0 - absent, the maximum 3 - pronounced
Time frame: 2 months
The effectiveness of therapy according to clinical examination.
The effectiveness of therapy according to clinical examination. Average score. The dynamics of clinical symptoms will be determined based on an assessment of the severity of intoxication (general) symptoms and respiratory complaints according to a 4-point system, where the minimum score is 0 - absent, the maximum 3 - pronounced
Time frame: 4 months
The effectiveness of therapy according to clinical examination.
The effectiveness of therapy according to clinical examination. Average score. The dynamics of clinical symptoms will be determined based on an assessment of the severity of intoxication (general) symptoms and respiratory complaints according to a 4-point system, where the minimum score is 0 - absent, the maximum 3 - pronounced
Time frame: 6 months
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy).
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy). Averages.
Time frame: 3 months
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy).
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy). Averages.
Time frame: 6 months
Mortality rate.
Mortality rate. The proportion of patients.
Time frame: 6 months
Plan to share: No
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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SPP Pharmaclon Ltd.