Efficacy and Safety of Intravenous Treatment of Tuberculosis

Yuria-Pharm

Status: Terminated

Conditions: Tuberculosis, Pulmonary

Treatments: Drug: Isoniazid; Drug: Rifampicin; Drug: Ethambutol

Study type: Observational

Funder types: Industry

Identifiers

NCT04150367

Invent-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. men and women;
2. The age of 18 - 65 years inclusive;
3. Patients diagnosed with: first diagnosed pulmonary tuberculosis;
4. 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);
5. 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 );
6. 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;
7. Provided informed written consent of the patient to participate in the study;
8. The patient's ability to adequately cooperate in the research process;
9. Patients with negative analysis of GenXpert MBT / RIF (at the time of screening, analysis results not older than 7 days may be used);
10. Oral consent of the patient to stop using alcohol during the study period.

Exclusion criteria

1. Patients who, according to the results of a sputum test using the GenXpert MBT / RIF method, are determined to be resistant to rifampicin.
2. Pregnancy, lactation;
3. Epilepsy and other diseases, which are accompanied by a tendency to convulsive seizures;
4. Severe psychosis;
5. Poliomyelitis (including in the anamnesis);
6. 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;
7. HIV infection;
8. Intolerance (including history) of any of the drugs studied;
9. 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 design

166 participants in 2 patient groups

Study group

Description:

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.

Treatment:

Drug: Ethambutol

Drug: Ethambutol

Drug: Rifampicin

Drug: Rifampicin

Drug: Isoniazid

Drug: Isoniazid

Control group

Description:

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.

Treatment:

Drug: Ethambutol

Drug: Ethambutol

Drug: Rifampicin

Drug: Rifampicin

Drug: Isoniazid

Drug: Isoniazid