Therapeutic drug monitoring of linezolid in Chinese patients
| ISRCTN | ISRCTN16840270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16840270 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | KY-IIT-20240701 |
| Sponsors | Zhejiang Pharmaceutical Association, Key Laboratory of Intelligent Pharmacy and Individualized Therapy of Huzhou |
| Funders | Zhejiang Pharmaceutical Association, Key Laboratory of Intelligent Pharmacy and Individualized Therapy of Huzhou |
- Submission date
- 27/08/2024
- Registration date
- 27/08/2024
- Last edited
- 27/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Linezolid is an antibiotic with a wide spectrum of antibacterial properties. There is still controversy over the individualized dosing regimen of linezolid. Therefore, it is particularly important to conduct studies in the Chinese patient population to determine the optimal therapeutic drug monitoring concentration range of linezolid and identify the risk factors for adverse reactions. This study established a research cohort for drug monitoring of linezolid treatment through a nationwide multicenter collaboration.
Who can participate?
Patients aged 18 years and over currently receiving treatment with linezolid
What does the study involve?
This study involved collecting blood samples from patients for 2 days, 6 times, and conducting a 28-day follow-up.
What are the possible benefits and risks of participating?
This study can help us find the optimal concentration range of linezolid and prevent adverse reactions. The risk of this study is relatively low, with the majority of risks being the possibility of slight discomfort during blood collection.
Where is the study run from?
Changxing People's Hospital (China)
When is the study starting and how long is it expected to run for?
December 2023 to September 2025
Who is funding the study?
1. Zhejiang Pharmaceutical Association (China)
2. Key Laboratory of Intelligent Pharmacy and Individualized Therapy of Huzhou (China)
Who is the main contact?
Bin Lin, lb_wzmc@126.com
Contact information
Public, Scientific, Principal investigator
2F-6# Building
No. 66 Taihu Road
Changxing
313100
China
 ORCID ID |
0000-0003-2222-8228 |
|---|---|
| Phone | +86 (0)13967299420 |
| lb_wzmc@126.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective multicenter observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Therapeutic drug monitoring of linezolid in Chinese patients: a prospective, multicenter, observational study |
| Study acronym | TULIP |
| Study objectives | Clarify the safety of linezolid Css in the Chinese patient population at 2-8 mg/L, as well as the increased risk of blood toxicity beyond 8 mg/L. |
| Ethics approval(s) |
Approved 16/08/2024, Changxing People's Hospital Ethics Committee for Clinical Research (2F-6# Building, No. 66 Taihu Road, Changxing, 313100, China; +86 (0)13511248946; cxmedethics@126.com), ref: 2024-EC-070 |
| Health condition(s) or problem(s) studied | Patients receiving treatment with linezolid |
| Intervention | 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 minutes after the end of infusion (peak concentration, Cmax), and 3 hours after the end of infusion. Continuous follow-up for 28 days to observe the occurrence of adverse events. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Linezolid |
| Primary outcome measure(s) |
1. Steady-state concentration (Css) of linezolid measured using UPLC-MS/MS on the 3rd and 7th day after medication |
| Key secondary outcome measure(s) |
1. Creatinine clearance rate measured using picric acid method on the 3rd and 7th day after medication |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Changxing
313100
China
Shanghai
200127
China
Xi‘an
710004
China
Wenzhou
325000
China
Shanghai
200025
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/08/2024: Study's existence confirmed by the Changxing People's Hospital Ethics Committee for Clinical Research.
