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Study on the Monitoring of Plasma Concentration and Penetration Rate in Lung Tissue of Contezolid Tablets in the Treatment of Pulmonary Infection

A prospective, single-center study on the blood drug concentration monitoring and lung tissue penetration rate of Contezolid tablets in the treatment of Gram-positive bacterial pulmonary infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101413
Enrollment
Unknown
Registered
2025-04-24
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Gram-positive pulmonary infection

Interventions

Steady state drug concentration determination group:The subjects were given the fifth dose and 1ml of blood was collected at each blood collection point for measuring plasma drug concentration
First dose drug concentration determination group:At each blood collection point, 1ml of blood was collected from the subjects during the first dose of medication to determine plasma drug concentratio
3h Drug concentration determination group in bronchoalveolar lavage fluid:Collect bronchoalveolar lavage fluid from subjects for determining drug concentration and urea concentration
6h Drug concentration determination group in bronchoalveolar lavage fluid:6h Collect bronchoalveolar lavage fluid from subjects for determining drug concentration and urea concentration
12h Drug concentration determination group in bronchoalveolar lavage fluid:12h Collect bronchoalveolar lavage fluid from subjects for determining drug concentration and urea concentration

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Age >=18 years; 2.Patients with lung infection caused by gram-positive bacteria; 3.According to the European Society of Critical Care Medicine (ESICM) definition of acute gastrointestinal injury (AGI) and the severity of the four-level scale, gastrointestinal function is judged as grade I and grade II patients;

Exclusion criteria

Exclusion criteria: 1.People who are allergic to oxazolidinones or have severe allergies; 2.Pregnant and lactating women; 3.It is not suitable for oral/nasal feeding/gastrointestinal nutrition tube administration, or there are gastrointestinal diseases that will seriously affect oral drug absorption; 4.Participants in other clinical trials; 5.Clinical trial participants deemed unsuitable by the investigator;

Design outcomes

Primary

MeasureTime frame
First dose blood drug concentration value,Steady state blood drug concentration value;Concentration values of Contezolid in alveolar lavage fluid;Steady state blood drug concentration value;The urea concentration value in the alveolar lavage fluid;

Countries

China

Contacts

Public ContactLi Yang

The First Affiliated Hospital of Xi'an Jiaotong University

doc_liyang@126.com+86 158 2976 0158

Outcome results

None listed

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