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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.
As one of the drugs for treating Mycobacterium abscessus infections, linezolid is effective but its use is limited in anti-Mycobacterium abscessus treatment regimens due to the high incidence of adverse reactions associated with long-term use. Contezolid, a new drug developed in China, belongs to the oxazolidinone class of drugs and shares a similar antibacterial spectrum with linezolid, while exhibiting a significantly better safety profile. This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the early bactericidal activity. It enrolls patients with Mycobacterium abscessus disease and administers a 14-day monotherapy of contezolid for the treatment of the disease. The study compares contezolid with linezolid, a classic anti-Mycobacterium abscessus drug, by analyzing colony forming units and Time To Positivity in sputum cultures. By assessing the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus disease, the study evaluates the early bactericidal activity of contezolid, providing a basis for the selection of new therapeutic options for the treatment of Mycobacterium abscessus disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contezolid group | Experimental | Contezolid 800mg twice daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of contezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. |
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| Linezolid group | Active Comparator | Linezolid 600mg once daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of linezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contezolid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Positivity in sputum cultures | With a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, then were compared with a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug, through analysis and comparison of Time To Positivity in sputum cultures. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenjuan Nie, Director | Beijing Tuberculosis & Thoracic Tumor Research Institute Beijing Chest Hospital affiliated to Capital Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute | Beijing | Beijing Municipality | 101149 | China |
In our hospital, the investigators are not allowed to casually publish participants' information and hospital data on the website.
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| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C000590780 | contezolid |
| D023303 | Oxazolidinones |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| linezolid | Drug | 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. |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000081 |
| Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |