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According to Sponsor decision.
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This Open-label, Randomized, Multicenter, Controlled, Parallel, Comparative Study will compare the efficacy and safety of intravenous treatment with Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of tuberculosis treatment and the treatment with the oral forms of Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of tuberculosis treatment for Patients With Widespread Destructive Pulmonary Tuberculosis With Bacterial Excretion.
There are two groups of patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion. The first group receives intravenous treatment with Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of tuberculosis treatment. The second group gets oral forms of Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of Tuberculosis treatment. Then both groups receive oral treatment of tuberculosis according to the known scheme.
Up to 318 participants will be randomized into this study, with 159 participants being randomized to the control arm and 159 participants being randomized to the experimental arm. It Supposed that not less than 254 participants will finish the study (about 127 participants in each arm) and their results will be included in the statistical analysis.
While the intensive phase participants of both arms will be hospitalized in the Tuberculosis Dispensary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion, who receive intravenous treatment with Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of tuberculosis treatment. Then group receives oral treatment of tuberculosis according to the known scheme. |
| |
| Control group | Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion, who receive oral forms of Isoniazid, Rifampicin, Ethambutol first two months of intensive phase of tuberculosis treatment. Then group receives oral treatment of tuberculosis according to the known scheme. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazid | Drug | Solution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with negative results of sputum analysis on Mycobacterium tuberculosis . | Percentage of patients with negative results of sputum analysis on Mycobacterium tuberculosis in the main and control groups. | Тhe end of the 1st month from the start of treatment (after taking 30 doses of each drug by the patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Time until the negative result of the Mycobacterium tuberculosis tests is obtained. | Time until the negative result of sputum Mycobacterium tuberculosis tests is obtained for each patient. | 2 weeks - 3 months |
| Combined percentage ratio of patients with negative results of Mycobacterium tuberculosis analysis and clinical improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage ratio of severe adverse events. | All kinds of adverse events. | From 1 week till 7 months after the start of treatment. |
| Comparative cost of treatment of the main disease and complications at 6 months after the start of the treatment. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Clinical Antituberculosis Dispensary | Chernivtsi | Ukraine | ||||
| Regional phthisiopulmonary center |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| D012293 | Rifampin |
| D012996 | Solutions |
| D004977 | Ethambutol |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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| Rifampicin | Drug | Participants will get the dosage according to the instruction for use. |
|
|
| Ethambutol | Drug | Participants will get the dosage according to the instruction for use. |
|
|
| Rifampicin | Drug | Participants will get the dosage according to the instruction for use. |
|
|
| Isoniazid | Drug | . Participants will get the dosage according to the instruction for use. |
|
|
| Ethambutol | Drug | Participants will get the dosage according to the instruction for use. |
|
|
Combined percentage ratio of patients who have negative results of sputum analysis on Mycobacterium tuberculosis and clinical improvement at the same time. |
| 2 months after the start of treatment (after taking the patient 60 doses of each preparation of the intensive phase). |
| Combined percentage of patients with no response to treatment in 12 months. | Combined percentage ratio of patients with no response to treatment in 12 months. | 12 months after the start of treatment (13 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
| Combined percentage ratio of patients with no response to treatment in 18 months. | Combined percentage ratio of patients with no response to treatment in 18 months. | 18 months after the start of treatment (19 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
| Combined percentage ratio of patients with relapse of active tuberculosis in 18 months. | Combined percentage ratio of patients with relapse of active tuberculosis in 18 months. | 18 months after the start of treatment (19 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
| Combined percentage ratio of patients with death due to active tuberculosis in 18 months. | Combined percentage ratio of patients with death due to active tuberculosis in 18 months. | 18 months after the start of treatment (19 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
| Combined percentage ratio of patients with relapse of active tuberculosis in 12 months. | Combined percentage ratio of patients with relapse of active tuberculosis in 12 months. | 12 months after the start of treatment (13 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
| Combined percentage ratio of patients with death due to active tuberculosis in 12 months. | Combined percentage ratio of patients with death due to active tuberculosis in 12 months. | 12 months after the start of treatment (13 months after initiation of treatment for patients who still have the positive results of the sputum analysis on Mycobacterium tuberculosis after taking 60 doses of each preparation of the intensive phase). |
Comparative cost of treatment of the main disease and complications based on the average cost of all medical services for the medical institutions participating in the study at 6 months after the start of treatment.
| 6 months after the start of treatment/ |
| Comparative cost of treatment of the main disease and complications at 12 months after the start of the treatment. | Comparative cost of treatment of the main disease and complications based on the average cost of all medical services for the medical institutions participating in the study at 12 months after the start of treatment. | 12 months after the start of treatment |
| Comparative cost of treatment of the main disease and complications at 18 months after the start of the treatment. | Comparative cost of treatment of the main disease and complications based on the average cost of all medical services for the medical institutions participating in the study at 18 months after the start of treatment. | 18 months after the start of treatment |
| Ivano-Frankivsk |
| Ukraine |
| Regional Antituberculosis Dispensary №1 | Kharkiv | Ukraine |
| Regional Antituberculosis Dispensary | Kherson | Ukraine |
| National Yanovsky's Institute of Phthisiology and Pulmonology | Kyiv | Ukraine |
| Regional territorial medical anti-tuberculosis association | Lutsk | Ukraine |
| Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center | Lviv | Ukraine |
| Regional Clinical Antituberculosis Dispensary | Sumy | Ukraine |
| Ternopil Regional TB Dispensary | Ternopil | Ukraine |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004364 | Pharmaceutical Preparations |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D004304 | Dosage Forms |