Therapeutic drug monitoring of linezolid in Chinese patients
Not Applicable
- Conditions
- Patients receiving treatment with linezolidNot Applicable
- Registration Number
- ISRCTN16840270
- Lead Sponsor
- Zhejiang Pharmaceutical Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1. Age =18 years old, male or female
2. Received intravenous anti-infective treatment with linezolid for suspected or confirmed Gram-positive bacterial infection, and should be treated for at least 2 days upon inclusion
3. Patients willing to undergo therapeutic drug monitoring
Exclusion Criteria
1. Previously received treatment with linezolid (either orally or intravenously) within the past month
2. Pregnant women
3. Child patients
4. Patients who refuse to be enrolled or are unable to obtain blood samples due to reasons such as unwillingness to cooperate with their family members
5. The patient's condition is critical and the estimated survival time is less than 48 hours
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Steady-state concentration (Css) of linezolid measured using UPLC-MS/MS on the 3rd and 7th day after medication<br>2. Incidence of thrombocytopenia evaluated through blood routine and adverse reaction records during the treatment period from the first day to the 28th day after medication<br>3. Incidence of anemia evaluated through blood routine and adverse reaction records during the treatment period from the first day to the 28th day after medication<br>4. Incidence of leukopenia evaluated through blood routine and adverse reaction records during the treatment period from the first day to the 28th day after medication<br>5. Incidence of other adverse reactions evaluated through blood routine and adverse reaction records during the treatment period from the first day to the 28th day after medication
- Secondary Outcome Measures
Name Time Method 1. Creatinine clearance rate measured using picric acid method on the 3rd and 7th day after medication<br>2. Duration of linezolid use recorded using case report form (CRF) during the treatment cycle<br>3. Concomitant use of other antibiotics recorded using case report form (CRF) during the treatment cycle<br>4. Underlying diseases recorded using case report form (CRF) during the treatment cycle<br>5. Neutrophil levels measured using automatic classification and counting method for blood cells on the 3rd and 7th day after medication<br>6. CRP levels measured using immunoturbidimetry on the 3rd and 7th day after medication<br>7. Procalcitonin levels measured using enzyme immunoassay on the 3rd and 7th day after medication<br>8. IL-6 levels measured using enzyme immunoassay on the 3rd and 7th day after medication