Gastrointestinal functional impairment with gram-positive infection
Conditions
Interventions
Contezolid gastric tube administration group:Contezolid tablets were added to the basic treatment regimen
Contezolid enteric administration group:Contezolid was administered through a bowel tube
Sponsors
The First Hospital of TsingHua University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male or female aged 18-75 years; (2) Patients admitted to ICU who have been confirmed by microbiology or have been suggested to be gram-positive bacteria in combination with clinical evidence; (3) The patient has decreased or expected decrease in laboratory indicators of the blood system (e.g., white blood cells, platelets, hemoglobin), or decreased renal function, or has other clinically relevant risk factors for the use of linezolid or vancomycin. (4) 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 evaluation is grade I and grade II patients. (5) Subjects (or their legal representatives/guardians) understand the study procedures and content, sign the informed consent, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: (1) People who are allergic or severely allergic to oxazolidinones (such as: atopic dermatitis, bronchial asthma). (2) Those who are not suitable for administration through nasal feeding/gastrointestinal nutrition tube, or have gastrointestinal diseases that will seriously affect oral drug absorption. (3) The expected survival time is less than 6 months. (4) Patients with immunodeficiency, such as congenital immunodeficiency, who are receiving immunosuppressive therapy or who are HIV-positive. (5) Those with shock related indications. (6) Patients whose gastrointestinal function is judged to be grade III or Grade IV according to AGI classification. (7) Abnormal QTC interval (QTc=500msec). (8) For systemic glucocorticoids, the dose equivalent to prednisone >20mg/ day, and continuous use for more than 2 weeks. (9) Received clinical research on other drugs or medical devices within 3 months before enrollment. (10) Those who are not suitable to participate in this clinical study or have an impact on the endpoint evaluation due to various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood test;Blood biochemical test;Electrocardiogram examination;Gastrointestinal ultrasonography;Bacteriological examination;Clinical efficacy evaluation;Microbiological efficacy evaluation;Routine urine test; | — |
Countries
China
Contacts
Public ContactYangong Chao
The First Hospital of TsingHua University
Outcome results
None listed