Cerebrospinal fluid penetration and pharmacokinetics of Contezolid Tablets in neurosurgical subjects with confirmed or suspected central nervous system infection

Cerebrospinal fluid penetration and pharmacokinetics of Contezolid Tablets in neurosurgical subjects with confirmed or suspected central nervous system infection - Study on the penetration and pharmacokinetics of Contezolid Tablets in cerebrospinal fluid in subjects with nervous system infection

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300071995

Enrollment

Unknown

Registered

2023-05-31

Start date

2023-06-01

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

Central nervous system infection

Interventions

Contezolid group:Contezolamide tablets will be used for 7 days

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male or female aged 18-75 years who underwent craniocerebral surgery with external ventricular drainage tube for various reasons; 2) Confirmed or suspected central nervous system infection after craniotomy; Objective: 3) AGI score (Acute Gastrointestinal injury) is = class 2 and it can be administered by gastric tube; 4) Female subjects must meet the following conditions: ? at least one year after menopause, ? have undergone sterilization, or ? if they are fertile, they must meet the following conditions: At the time of enrollment, ask the patient to confirm that she is non-pregnant in the form of medical history inquiry, take reliable contraceptive measures during the trial, and be non-lactating; 5) Male and female subjects should take effective contraceptive measures during the study period and one month after the end of the study; 6) Subjects (or their legal representative/guardian) understand the study procedure and content, sign the informed consent, and are willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Compound external injuries with other injuries (such as pulmonary hemorrhage, hemophothorax, intestinal perforation, spleen rupture, etc.); 2) congenital central nervous system malformation; 3) Those who are expected to survive for less than 6 months; 4) persistent epilepsy; 5) Patients with severe liver and kidney function impairment; 6) People with mental diseases; 7) People who are allergic or severely allergic to oxazolidinones; 8) Human immunodeficiency virus (HIV) positive; 9) Those who are not suitable to participate in the clinical study or have influence on the study evaluation due to various reasons.

Design outcomes

Primary

Measure	Time frame
Penetration of brain tissue;Pharmacokinetic parameters;	—

Secondary

Measure	Time frame
Blood routine;Blood biochemistry;Urine routine;Routine and biochemistry of cerebrospinal fluid;Lactic acid content in cerebrospinal fluid;Electrocardiogram examination;Adverse event;	—

Countries

China

Contacts

Public ContactGuangzhi Shi

Beijing Tiantan Hospital, Capital Medical University

shigzh@yahoo.com.cn+86 136 0111 0669

Outcome results

None listed

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