Pulmonary TuberculosisNCT05359315
Study on the Use of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
An observational study of Pulmonary Tuberculosis, run by SPP Pharmaclon Ltd. at 1 site in Russia.
Trial 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 solution for injection for intramuscular or subcutaneous administration of 500,000 IU. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Interferon-Gamma
- How many people
- 84 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2022to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with drug-resistant pulmonary tuberculosis with bacterial excretion
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
FSBI "NMIC FPI" of the Ministry of Health of Russia
Moscow, 127473
Anastasia G Samoilova, Dr. med., 8107 (495) 631-15-15, a.samoilova.nmrc@mail.ru
Dar'ja P Korneva, Master, 8107 (495) 631-15-15 ext. 5004, kornevadp@nmrc.ru
About this study
Official title: An Open Prospective Observational Study Evaluating the Efficacy and Tolerability of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
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.
Read the 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 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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Interferon-Gamma
- Keywords
- treatment of drug-resistant pulmonary tuberculosis, interferon gamma, drug resistant
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-GammaDrug
Also called Ingaron, Interferon gamma human recombinant
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Ingaron + basic TB therapy 500,000 IU once daily for 3 months followed by 3 months follow-up Receives: Drug: Interferon-Gamma | |
| No Intervention | only basic anti-tuberculosis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 1 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 1 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 2 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 2 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 3 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 3 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 4 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 4 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 5 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 5 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Percentage of patients.
Measured: 6 months
Sputum smear conversion according to microscopy.
Sputum smear conversion according to microscopy. Mean time to clinical response.
Measured: 6 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 1 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 1 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 2 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 2 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 3 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 3 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 4 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 4 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 5 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 5 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Percentage of patients.
Measured: 6 months
Sputum smear conversion by culture.
Sputum smear conversion by culture. Mean time to clinical response.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Mortality rate.
Mortality rate. The proportion of patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 Apr 2022
- Primary completion1 Aug 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPP Pharmaclon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anatoly I Saulin, Master, Study director, SPP Pharmaclon Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359315
- Sponsor's protocol ID
- STING-2021
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Prospective Observational Study Evaluating the Efficacy and Tolerability of Interferon Gamma (Ingaron) Injections in Patients With Drug-resistant Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT05359315
- Acronym / sponsor ID
- STING-2021
- Conditions
- Pulmonary Tuberculosis
- Keywords
- treatment of drug-resistant pulmonary tuberculosis, interferon gamma, drug resistant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- SPP Pharmaclon Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: Interferon-GammaIngaron + basic TB therapy 500,000 IU once daily for 3 months followed by 3 months follow-up |
| No Intervention | – | –only basic anti-tuberculosis therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with drug-resistant pulmonary tuberculosis with bacterial excretion
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-GammaAlso: Ingaron, Interferon gamma human recombinantreceived by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | Drug | Experimental |
Primary outcome
Sputum smear conversion according to microscopy.
Time frame: 1 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 1 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion according to microscopy.
Time frame: 2 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 2 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion according to microscopy.
Time frame: 3 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 3 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion according to microscopy.
Time frame: 4 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 4 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion according to microscopy.
Time frame: 5 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 5 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion according to microscopy.
Time frame: 6 months
Sputum smear conversion according to microscopy. Percentage of patients.
Sputum smear conversion according to microscopy.
Time frame: 6 months
Sputum smear conversion according to microscopy. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 1 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 1 months
Sputum smear conversion by culture. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 2 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 2 months
Sputum smear conversion by culture. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 3 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 3 months
Sputum smear conversion by culture. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 4 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 4 months
Sputum smear conversion by culture. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 5 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 5 months
Sputum smear conversion by culture. Mean time to clinical response.
Sputum smear conversion by culture.
Time frame: 6 months
Sputum smear conversion by culture. Percentage of patients.
Sputum smear conversion by culture.
Time frame: 6 months
Sputum smear conversion by culture. Mean time to clinical response.
10 secondary outcomes
The effectiveness of therapy according to X-ray examination of the chest.
Time frame: 2 months
The effectiveness of therapy according to X-ray examination of the chest.
Time frame: 4 months
The effectiveness of therapy according to X-ray examination of the chest.
Time frame: 6 months
The effectiveness of therapy according to computed tomography of the chest.
Time frame: 6 months
The effectiveness of therapy according to clinical examination.
Time frame: 2 months
The effectiveness of therapy according to clinical examination.
Time frame: 4 months
The effectiveness of therapy according to clinical examination.
Time frame: 6 months
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy).
Time frame: 3 months
Change in immunological status (CD4 and CD8 lymphocyte populations) compared with baseline values (before therapy).
Time frame: 6 months
Mortality rate.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoly I Saulin, Master study director
SPP Pharmaclon Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis, run by SPP Pharmaclon Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia A Isakova, Master (8 107 905 535-33-11, isakova@pharmaclon.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum smear conversion according to microscopy. (time frame: 1 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.