Tuberculosis, PulmonaryNCT04150367
Efficacy and Safety of Intravenous Treatment of Tuberculosis
An observational study of Tuberculosis, Pulmonary, run by Yuria-Pharm at 9 sites in Ukraine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Isoniazid, Rifampicin and Ethambutol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 166 participants
- Where
- 9 sitesUkraine
- Study dates
- 3 Mar 2017to 14 Jul 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion.
Who may be able to join
- men and women;
- The age of 18 - 65 years inclusive;
- Patients diagnosed with: first diagnosed pulmonary tuberculosis;
- Patients with at least one positive result of a microbiological study of the sputum on the Mycobacterium tuberculosis (during the screening, the results of a microbiological sputum examination on an Mycobacterium tuberculosis up to 7 days old can be used);
- Patients with radiographically and optionally CT confirmed cavity / cavities of destruction in the lungs, as well as a widespread tuberculosis process (occupying at least 2 segments of the lungs) (during the screening, the results of X-ray examination of the chest up to 7 days old can be used );
- For women with reproductive potential - negative result of urine test for pregnancy and consent to use a reliable method of contraception before the end of the study;
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- Provided informed written consent of the patient to participate in the study;
- The patient's ability to adequately cooperate in the research process;
- Patients with negative analysis of GenXpert MBT / RIF (at the time of screening, analysis results not older than 7 days may be used);
- Oral consent of the patient to stop using alcohol during the study period.
Who cannot join
- Patients who, according to the results of a sputum test using the GenXpert MBT / RIF method, are determined to be resistant to rifampicin.
- Pregnancy, lactation;
- Epilepsy and other diseases, which are accompanied by a tendency to convulsive seizures;
- Severe psychosis;
- Poliomyelitis (including in the anamnesis);
- Diseases of the cardiovascular system, respiratory system, diabetes mellitus, impaired liver function, kidney, thyroid gland, vision, the presence of concomitant diseases or acute conditions, which, according to the researcher, do not allow the patient to participate in this study;
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- HIV infection;
- Intolerance (including history) of any of the drugs studied;
- Participation in any other clinical trial at the time of inclusion in this study and for the last 30 days before the date of screening.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Ukraine9 sites
Regional Clinical Antituberculosis Dispensary
Chernivtsi
Regional phthisiopulmonary center
Ivano-Frankivsk
Regional Antituberculosis Dispensary №1
Kharkiv
Regional Antituberculosis Dispensary
Kherson
National Yanovsky's Institute of Phthisiology and Pulmonology
Kyiv
Regional territorial medical anti-tuberculosis association
Lutsk
Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center
Lviv
Regional Clinical Antituberculosis Dispensary
Sumy
Ternopil Regional TB Dispensary
Ternopil
About this study
Official title: Open-label, Randomized, Multicenter, Controlled, Parallel, Comparative Study of Efficacy and Safety of Treatment of Tuberculosis With Isoniazid, Rifampicin, Ethambutol for Intravenous Infusion in Comparison With Oral Forms While the Intensive Phase of Treatment for Patients With Widespread Destructive Pulmonary Tuberculosis With Bacterial Excretion.
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.
Read the detailed description
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.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Isoniazid, Rifampicin, Ethambutol
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
Also called Bitub
Solution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use.
RifampicinDrug
Also called Rifampin, Lyophilisate for solution for infusion 600 mg.
Participants will get the dosage according to the instruction for use.
EthambutolDrug
Also called Inbutol, Solution for injections100 mg/ml, 20 ml.
Participants will get the dosage according to the instruction for use.
RifampicinDrug
Also called Rifampicin 150 mg Capsules
Participants will get the dosage according to the instruction for use.
IsoniazidDrug
Also called Isoniazid, Tablets, 300mg.
. Participants will get the dosage according to the instruction for use.
EthambutolDrug
Also called Ethambutol, Tablets 400 mg.
Participants will get the dosage according to the instruction for use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol | |
| 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. Receives: Drug: Rifampicin; Drug: Isoniazid; Drug: Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Тhe end of the 1st month from the start of treatment (after taking 30 doses of each drug by the patient)
Secondary outcomes (8)
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.
Measured: 2 weeks - 3 months
Combined percentage ratio of patients with negative results of Mycobacterium tuberculosis analysis and clinical improvement.
Combined percentage ratio of patients who have negative results of sputum analysis on Mycobacterium tuberculosis and clinical improvement at the same time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start3 Mar 2017
- Primary completion14 Jul 2018
- Study completion14 Jul 2018
Why it stopped: According to Sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuria-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150367
- Sponsor's protocol ID
- Invent-1
- Status last verified
- Nov 2019
- First submitted
- 25 Oct 2017
- Last updated
- 7 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Multicenter, Controlled, Parallel, Comparative Study of Efficacy and Safety of Treatment of Tuberculosis With Isoniazid, Rifampicin, Ethambutol for Intravenous Infusion in Comparison With Oral Forms While the Intensive Phase of Treatment for Patients With Widespread Destructive Pulmonary Tuberculosis With Bacterial Excretion.
- ClinicalTrials.gov ID
- NCT04150367
- Acronym / sponsor ID
- Invent-1
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: According to Sponsor decision.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Yuria-PharmIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 4 Nov 2019 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Isoniazid, Drug: Rifampicin, Drug: EthambutolPatients 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 | – | Drug: Rifampicin, Drug: Isoniazid, Drug: EthambutolPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion.
Key inclusion criteria (10 listed)
- men and women;
- The age of 18 - 65 years inclusive;
- Patients diagnosed with: first diagnosed pulmonary tuberculosis;
- Patients with at least one positive result of a microbiological study of the sputum on the Mycobacterium tuberculosis (during the screening, the results of a microbiological sputum examination on an Mycobacterium tuberculosis up to 7 days old can be used);
- Patients with radiographically and optionally CT confirmed cavity / cavities of destruction in the lungs, as well as a widespread tuberculosis process (occupying at least 2 segments of the lungs) (during the screening, the results of X-ray examination of the chest up to 7 days old can be used );
Key exclusion criteria (9 listed)
- Patients who, according to the results of a sputum test using the GenXpert MBT / RIF method, are determined to be resistant to rifampicin.
- Pregnancy, lactation;
- Epilepsy and other diseases, which are accompanied by a tendency to convulsive seizures;
- Severe psychosis;
- Poliomyelitis (including in the anamnesis);
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 |
|---|---|---|
| IsoniazidAlso: BitubSolution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use. | Drug | Study group |
| RifampicinAlso: Rifampin, Lyophilisate for solution for infusion 600 mg.Participants will get the dosage according to the instruction for use. | Drug | Study group |
| EthambutolAlso: Inbutol, Solution for injections100 mg/ml, 20 ml.Participants will get the dosage according to the instruction for use. | Drug | Study group |
| RifampicinAlso: Rifampicin 150 mg CapsulesParticipants will get the dosage according to the instruction for use. | Drug | Control group |
| IsoniazidAlso: Isoniazid, Tablets, 300mg.. Participants will get the dosage according to the instruction for use. | Drug | Control group |
| EthambutolAlso: Ethambutol, Tablets 400 mg.Participants will get the dosage according to the instruction for use. | Drug | Control group |
Primary outcome
Percentage of patients with negative results of sputum analysis on Mycobacterium tuberculosis .
Time frame: Тhe end of the 1st month from the start of treatment (after taking 30 doses of each drug by the patient)
Percentage of patients with negative results of sputum analysis on Mycobacterium tuberculosis in the main and control groups.
8 secondary outcomes
Time until the negative result of the Mycobacterium tuberculosis tests is obtained.
Time frame: 2 weeks - 3 months
Combined percentage ratio of patients with negative results of Mycobacterium tuberculosis analysis and clinical improvement.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Results and safety
The study was stopped early (reason given: According to Sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Yuria-Pharm at 9 sites in Ukraine.
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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ukraine. 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?
The study was stopped early (reason given: According to Sponsor decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with negative results of sputum analysis on Mycobacterium tuberculosis . (time frame: Тhe end of the 1st month from the start of treatment (after taking 30 doses of each drug by the patient)). 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 7 Nov 2019.