Efficacy and Safety of Intravenous Treatment of Tuberculosis

NCT04150367 | Terminated

• 1 other identifier: Invent-1
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 9

Brief 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 first two months of intensive phase of tuberculosis treatment for Patients With Widespread Destructive Pulmonary Tuberculosis With Bacterial Excretion.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• Time until the negative result of the Mycobacterium tuberculosis tests is obtained.

  2 weeks - 3 months

• Combined percentage ratio of patients with negative results of Mycobacterium tuberculosis analysis and clinical improvement.

  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.

  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.

  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.

  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).

Other Outcomes (4)

• Percentage ratio of severe 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.

  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.

  12 months after the start of treatment

Study Arms (2)

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.

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.

Drug: Rifampicin; Drug: Isoniazid; Drug: Ethambutol

Interventions

Isoniazid DRUG

Solution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use.

Also known as: Bitub

Study group

Rifampicin DRUG

Participants will get the dosage according to the instruction for use.

Also known as: Rifampin, Lyophilisate for solution for infusion 600 mg.

Study group

Ethambutol DRUG

Participants will get the dosage according to the instruction for use.

Also known as: Inbutol, Solution for injections100 mg/ml, 20 ml.

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with first diagnosed widespread destructive pulmonary tuberculosis with bacterial excretion.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• HIV infection;
• Intolerance (including history) of any of the drugs studied;

Sponsors & Collaborators

• Yuria-Pharm: lead

Study Sites (9)

Regional Clinical Antituberculosis Dispensary

Chernivtsi, Ukraine

Location

Regional phthisiopulmonary center

Ivano-Frankivsk, Ukraine

Location

Regional Antituberculosis Dispensary №1

Kharkiv, Ukraine

Location

Regional Antituberculosis Dispensary

Kherson, Ukraine

Location

National Yanovsky's Institute of Phthisiology and Pulmonology

Kyiv, Ukraine

Location

Regional territorial medical anti-tuberculosis association

Lutsk, Ukraine

Location

Lviv Regional Phthisiopneumological Clinical Treatment and Diagnostic Center

Lviv, Ukraine

Location

Regional Clinical Antituberculosis Dispensary

Sumy, Ukraine

Location

Ternopil Regional TB Dispensary

Ternopil, Ukraine

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Isoniazid; Rifampin; Solutions; Ethambutol; Tablets

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Pharmaceutical Preparations; Ethylenediamines; Diamines; Polyamines; Amines; Dosage Forms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 4, 2019
• Study Start: March 3, 2017
• Primary Completion: July 14, 2018
• Study Completion: July 14, 2018
• Last Updated: November 7, 2019

Record last verified: 2019-11

Locations

UA (9)