Patients receiving treatment with linezolid Not Applicable
Conditions
Interventions
This study collected three venous blood samples from patients on the 3rd and 7th day after receiving linezolid treatment, 30 minutes before the start of administration (trough concentration, Cmin), 30
Sponsors
Zhejiang Pharmaceutical Association
Key Laboratory of Intelligent Pharmacy and Individualized Therapy of Huzhou
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Steady-state concentration (Css) of linezolid measured using UPLC-MS/MS on the 3rd and 7th day after medication 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 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 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 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
| Measure | Time frame |
|---|---|
| 1. Creatinine clearance rate measured using picric acid method on the 3rd and 7th day after medication 2. Duration of linezolid use recorded using case report form (CRF) during the treatment cycle 3. Concomitant use of other antibiotics recorded using case report form (CRF) during the treatment cycle 4. Underlying diseases recorded using case report form (CRF) during the treatment cycle 5. Neutrophil levels measured using automatic classification and counting method for blood cells on the 3rd and 7th day after medication 6. CRP levels measured using immunoturbidimetry on the 3rd and 7th day after medication 7. Procalcitonin levels measured using enzyme immunoassay on the 3rd and 7th day after medication 8. IL-6 levels measured using enzyme immunoassay on the 3rd and 7th day after medication | — |
Countries
China
Contacts
Public ContactBin Lin
Outcome results
None listed