Clinical Trials Logo
  1. Home
  2. Pulmonary Tuberculosis
  3. NCT04608955

Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081 — WX-081  

Pulmonary Tuberculosis Clinical Trial

Official title:
A Multi-center, Randomized, Positive-controlled Phase 2 Clinical Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of WX-081 in Participants With Drug-naive&Susceptible or Drug-Resistant Pulmonary Tuberculosis

Clinical Trial Summary

This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.

Clinical Trial Description

This is a Phase 2, multi-center, randomized, parallel, open-label, positive-controlled clinical trial. The objective of this trial is to evaluate the early bactericidal activity, safety and tolerability of WX-081 patients with drug-naive&susceptible and drug-resistant tuberculosis. and the efficacy in participants with drug-resistant tuberculosis. This trial will be divided into core research stage (stage 1) and extended research stage (stage 2). During stage 1, a panel of 59 participants with drug-naive&susceptible tuberculosis will be randomized to receive either WX-081(including 3 groups:150mg qd, 300mg qd, 450mg qd. n=12 per group) or standard treatment (n=8) for 2 weeks, and then followed by a follow-up period of 2 weeks. A panel of 40 participants with drug-resistant tuberculosis will be randomized to receive either WX-081 (400mg qd, n=20) or bedaquiline (400mg qd, n=20) for 2 weeks. During stage 2, the 40 participants with drug-resistant tuberculosis will receive WX-081(150mg qd) + MBT treatment (ie. multi-drug background treatment) and bedaquiline (200mg tiw) +MBT treatment for 6 weeks respectively, and then followed by a follow-up period of 4 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04608955
Study type Interventional
Source Shanghai Jiatan Pharmatech Co., Ltd
Contact
Status Completed
Phase Phase 2
Start date October 16, 2020
Completion date April 13, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT02736864 - Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae N/A
Not yet recruiting NCT04055441 - A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
Completed NCT02349841 - Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis Phase 2
Completed NCT01927159 - Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers Phase 1
Active, not recruiting NCT01691534 - Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) Phase 2
Completed NCT00803322 - Improving Community Based Tuberculosis Care in Ethiopia Phase 4
Completed NCT00834353 - Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis N/A
Withdrawn NCT03277742 - Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz N/A
Completed NCT00057434 - Vitamin A Therapy for Tuberculosis Phase 3
Recruiting NCT06127641 - Rehabilitation of People With Post-tuberculosis Lung Disease N/A
Recruiting NCT06058299 - Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis Phase 2
Completed NCT04550832 - PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE) Phase 2
Completed NCT02912832 - Prospective Assessment of TBDx Feasibility N/A
Completed NCT01215851 - Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) Phase 2
Recruiting NCT01503099 - Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease N/A
Recruiting NCT05046366 - Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.
Completed NCT05896930 - Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis Phase 2
Completed NCT02279875 - A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001) Phase 2
Completed NCT02554318 - Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia N/A
Completed NCT02053129 - Evaluation of PTB Screening in ANC in Lusaka, Zambia N/A