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A prospective, multicenter, one-arm study of the efficacy, safety, and tissue penetration of oral Contezolid Tablets in adult patients with pneumonia

A prospective, multicenter, one-arm study of the efficacy, safety, and tissue penetration of oral Contezolid Tablets in adult patients with pneumonia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067397
Enrollment
Unknown
Registered
2023-01-06
Start date
2022-12-30
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia

Interventions

Group 1:Contezolid Tablets were taken orally for 7-14 days

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Men or women aged >= 18 who are clinically diagnosed with pneumonia and who need to be treated with contezolid tablets for pneumonia; 2. Microbiological testing is required at the time of baseline admission; 3. Among the 20 subjects who plan to enroll, if at least 12 subjects need to collect alveolar lavage fluid to determine the drug concentration, they need to meet the need for further condition evaluation 48 hours after the initial medication, and have alveolar lavage fluid. Pneumonia subjects with washing indications; 4. Female subjects must meet the following conditions: ?menopause for at least 1 year, or ?have undergone sterilization, or ?those with fertility need to meet the following conditions at the same time: urine pregnancy test is negative at the time of enrollment, and reliable contraceptive measures are taken during the test Those who are not breast-feeding; 5. Male and female subjects need to take effective contraceptive measures during the study period and 1 month after the end of the study; 6. Those who can take the trial drug orally and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with confirmed or suspected viral pneumonia; 2. Known bronchial obstruction or history of obstructive pneumonia; 3. Known structural lung diseases, such as bronchiectasis, cystic pulmonary fibrosis; 4. Primary or metastatic lung cancer; 5. If the smear or culture result of the secretion of the infection site is only G-bacteria, if it is a mixed infection of G+ bacteria and G-bacteria (G+ is the dominant bacteria), it is not excluded, and G-antibacterial drugs (Aztrexate) should be used in combination according to clinical needs. South or other antimicrobials effective only for G-); 6. People with known bloodstream infection or positive blood culture; 7. Those who need invasive mechanical ventilation therapy; 8. Those who must use vasoconstrictors for septic shock; 9. Patients with PORT/PSIV grade CAP who need to be admitted to the intensive care unit; 10. Known or suspected active tuberculosis; 11. Pneumocystis pneumonia; 12. Subjects who have received effective antibiotic therapy for more than 48 hours in the past 72 hours, unless it is recorded as treatment failure (treatment for 72 hours and no response); 13. For oxazolidine researchers, any situation that may endanger the safety of subjects or affect the evaluation of efficacy; subjects allergic to ketones; 14. People who are positive for human immunodeficiency virus (HIV); 15. The investigator believes that any situation that may endanger the safety of the subject or affect the evaluation of the efficacy.

Design outcomes

Primary

MeasureTime frame
Clinical effect;Microbiological efficacy;

Countries

China

Contacts

Public ContactJing Zhang

Zhongshan Hospital Fudan University

jingatlas@outlook.com+86 134 7278 2754

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026