Tuberculosis, Pulmonary Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06084715 -
The INSTITUT Study
|
||
| Terminated |
NCT03028129 -
Prevention of Tuberculosis in Prisons
|
Phase 4 | |
| Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
| Withdrawn |
NCT03862248 -
Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
|
Phase 3 | |
| Completed |
NCT03271567 -
Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients
|
||
| Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
| Recruiting |
NCT04919239 -
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
|
Phase 2 | |
| Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
| Recruiting |
NCT05926466 -
BTZ-043 Dose Evaluation in Combination and Selection
|
Phase 2 | |
| Recruiting |
NCT04752592 -
Evaluation of a Rapid Point-of-Care Serological Triage Test for Active TB
|
N/A | |
| Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
| Not yet recruiting |
NCT04968886 -
TuBerculosis Viability Interregional Study and Agreement on Biological Tests
|
||
| Not yet recruiting |
NCT04485156 -
Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)
|
Phase 3 | |
| Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
| Completed |
NCT01364324 -
Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients
|
||
| Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
| Completed |
NCT05899400 -
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
|
||
| Recruiting |
NCT04938596 -
Airborne Preventive Measures to Reduce New TB Infections in Household Contacts
|
N/A | |
| Recruiting |
NCT05455112 -
Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis
|
Phase 2 | |
| Completed |
NCT03044158 -
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
|
N/A |