Therapeutic drug monitoring of linezolid in Chinese patients
| ISRCTN | ISRCTN16840270 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16840270 |
| Secondary identifying numbers | KY-IIT-20240701 |
- Submission date
- 27/08/2024
- Registration date
- 27/08/2024
- Last edited
- 27/08/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
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
| Study design | Prospective multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Therapeutic drug monitoring of linezolid in Chinese patients: a prospective, multicenter, observational study |
| Study acronym | TULIP |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | Pharmacokinetic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Linezolid |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 12/12/2023 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/09/2024 |
| Recruitment end date | 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
Sponsor information
Research organisation
96 Daguan Road
Hangzhou
310011
China
| Phone | +86 (0)571 87245802 |
|---|---|
| runcongz@163.com | |
| Website | https://www.zjpha.com/ |
Research organisation
No. 66 Taihu Road
Changxing
313100
China
| Phone | +86 (0)6267652 |
|---|---|
| lb_wzmc@126.com |
Funders
Funder type
Other
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- 浙江省医药行业协会, ZIPA
- Location
- China
No information available
Results and Publications
| Intention to publish date | 30/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal after the end of the study. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
27/08/2024: Study's existence confirmed by the Changxing People's Hospital Ethics Committee for Clinical Research.
