Prospective, single-center, one-arm study of the efficacy, safety, bone tissue and fluid penetration of oral Contezolid Tablets in the prevention of infection during hip and knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300067584

Enrollment

Unknown

Registered

2023-01-12

Start date

2023-01-12

Completion date

Unknown

Last updated

2024-07-29

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

Conditions

Hip and knee replacement to prevent infection

Interventions

Test group:Take at least 4 doses of Contezolid Tablets orally before surgery

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female >=18 years old who underwent hip and knee arthroplasty for the first time due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, or aseptic necrosis of the femoral head; 2. Female subjects must meet the following conditions: (1) At least one year after menopause, or; (2) Have undergone sterilization, or; (3) If they are fertile, they must meet the following conditions: negative urine pregnancy test at the time of admission, reliable contraceptive measures taken during the test, and a non-lactation period; 3. Male and female subjects should take effective contraceptive measures during the study period and one month after the end of the study; 4. 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. Patients who are allergic or severely allergic to oxazolidinones; 2. Patients with gastrointestinal diseases that cannot be administered orally or are not suitable for administration through nasal feeding/gastrointestinal nutrition tube, or can seriously affect oral drug absorption; 3. Patients with poor blood pressure control; 4. Patients with poor blood glucose control; 5. Patients with severe damage of liver and kidney function; 6. Patients with mental disorders; 7. Patients with hematologic malignancy or myelosuppression; 8. Human immunodeficiency virus (HIV) positive patients; 9. Patients who are considered by the investigator to be ineligible to participate in the clinical study or have influence on the study evaluation for various reasons.

Design outcomes

Primary

Measure	Time frame
Clinical effect;Blood concentration;Drug concentration in tissue;	—

Countries

China

Contacts

Public ContactFeng Yin

East Hospital Tongji University

001yinfeng@sina.com+86 139 0182 4938

Outcome results

None listed

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