Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contezolid, linezolid.
- Who it may be relevant to
- Registry conditions: Monotherapy, Mycobacterium Abscessus Infection. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Time To Positivity in sputum cultures [Time frame: 14 days]
Eligibility criteria
Inclusion criteria
- Male or female aged between 18 and 65 years old;
- Weight ranging from 40 kg to 90 kg;
- At least one positive sputum culture for Mycobacterium abscessus within 6 months prior to screening, and one positive sputum culture for Mycobacterium abscessus with molecular species identification during the screening period within 1 month prior to the study;
- Voluntary participation in this study and signing of the informed consent form; (5) Male and female participants must use effective contraception during the study and for 1 month after the study ends.
Exclusion criteria
- Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening;
- Pregnant women, postpartum women, and lactating patients;
- Patients with a history of bedaquiline allergy or known hypersensitivity, or a history of severe adverse reactions;
- Patients with evidence of bedaquiline resistance;
- Patients deemed unsuitable for participation in this study by the investigator's assessment;
- Patients whom the investigator believes participation in this study would harm their health, or who are unlikely to comply with the scheduled visits and assessments as outlined in the protocol, and therefore are not suitable for participation in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Th — Beijing
Identifiers
NCT: NCT07372781 · GCP-TB-2024-11-15