Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis

Launched by BEIJING CHEST HOSPITAL · Jan 31, 2025

Keywords

ClinConnect Summary

This is a Phase II clinical study in Beijing that tests a new antibiotic called contezolid for tuberculous meningitis (a TB infection that affects the brain and its coverings). Researchers will compare contezolid to an older drug, linezolid, to see how the two drugs work in this illness. About 24 patients will be enrolled and randomly assigned to one of the two drugs for 7 days. The main thing the study will measure is how much of each drug is present in the blood and in the cerebrospinal fluid (the fluid around the brain and spine) after 7 days of treatment, using blood tests and a lumbar puncture to collect CSF.

Who may be eligible: adults, children, and older adults who are in the hospital and have been diagnosed with tuberculous meningitis within the past 3 months. Participants must be willing to participate, use effective contraception during the study and for 1 month after, and not have pregnancy, allergies to contezolid or linezolid, long-term immune-suppressing therapy, or known drug resistance to these medications. They will receive contezolid 800 mg once daily or linezolid 600 mg once daily for 7 days at Beijing Chest Hospital. The study is currently enrolling by invitation and is expected to complete around the end of 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Inpatients who have been diagnosed with or clinically diagnosed with tuberculous meningitis within the past 3 months prior to screening; (2) Voluntarily participate in this study and sign the informed consent form; (3) Male and female participants must use effective contraception during the study and for 1 month after the study ends.
• Exclusion Criteria:
• • (1) Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening; (2) Pregnant women, patients in the puerperium, and lactating women; (3) Patients with a history of allergy or known hypersensitivity to contezolid or linezolid, or a history of severe adverse reactions; (4) Patients with evidence of resistance to contezolid or linezolid; (5) Patients deemed unsuitable for participation in this study by the investigator's assessment; (6) Patients whom the investigator believes participation in this study would harm their health, or who are deemed unable to comply with the scheduled visits and assessments as outlined in the protocol, and therefore unsuitable for participation in this study.