NCT04150367

Efficacy and Safety of Intravenous Treatment of Tuberculosis

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.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 166 (actual)
• Sponsor: Yuria-Pharm · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Isoniazid	Solution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use.
DRUG	Rifampicin	Participants will get the dosage according to the instruction for use.
DRUG	Ethambutol	Participants will get the dosage according to the instruction for use.
DRUG	Rifampicin	Participants will get the dosage according to the instruction for use.
DRUG	Isoniazid	. Participants will get the dosage according to the instruction for use.
DRUG	Ethambutol	Participants will get the dosage according to the instruction for use.

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-07-14
• Completion: 2018-07-14
• First posted: 2019-11-04
• Last updated: 2019-11-07

Locations

9 sites across 1 country: Ukraine