Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
NCT07372781 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-01-28
Summary
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.
Conditions
- Monotherapy
- Mycobacterium Abscessus Infection
Interventions
- DRUG
-
Contezolid
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
- DRUG
-
linezolid
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of linezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
Sponsors & Collaborators
-
Beijing Chest Hospital
lead OTHER
Principal Investigators
-
Wenjuan Nie, Director · Beijing Tuberculosis & Thoracic Tumor Research Institute Beijing Chest Hospital affiliated to Capital Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-01
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
More Related Trials
-
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
NCT00523926 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Study of XJ101 in Chinese Healthy Subjects
NCT06014736 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
NCT00449644 ·Status: COMPLETED ·Phase: PHASE2
-
An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
NCT02365623 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase Ⅱ Clinical Study of 9MW1411 Injection in Acute Bacterial Skin and Skin Structure Infections
NCT05339802 ·Status: UNKNOWN ·Phase: PHASE2
-
Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
NCT02877927 ·Status: COMPLETED ·Phase: PHASE3
-
Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice
NCT01212601 ·Status: COMPLETED
-
A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection
NCT04784312 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
NCT01215851 ·Status: COMPLETED ·Phase: PHASE2
-
Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)
NCT02378480 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Evaluation of the Residual Antimicrobial Activity
NCT04495920 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult Volunteers
NCT05942820 ·Status: TERMINATED ·Phase: PHASE1
-
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
NCT01170221 ·Status: COMPLETED ·Phase: PHASE3
-
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT00865280 ·Status: TERMINATED ·Phase: PHASE3
-
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Ascending Doses of BWC0977 in Healthy Volunteers
NCT07029932 ·Status: RECRUITING ·Phase: PHASE1
-
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT03716024 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT00949130 ·Status: COMPLETED ·Phase: PHASE2
-
The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis
NCT05664568 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of the Efficacy and Safety of MEDI4893
NCT02296320 ·Status: COMPLETED ·Phase: PHASE2
-
Diagnostic Evaluation Study of the BactInsight Blood Culture System in West-Africa
NCT05722184 ·Status: COMPLETED
-
Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
NCT00150332 ·Status: COMPLETED ·Phase: PHASE3
-
AMR-DetecTool for the Diagnostic of MDR Bacterial Infections
NCT05378217 ·Status: COMPLETED
-
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
NCT05306223 ·Status: UNKNOWN ·Phase: PHASE4
-
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
NCT02279875 ·Status: COMPLETED ·Phase: PHASE2
-
A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis
NCT02684240 ·Status: COMPLETED ·Phase: PHASE2