Unique ID issued by UMIN | UMIN000004322 |
---|---|
Receipt number | R000005181 |
Scientific Title | A relationship between linezolid-induced myelosuppression and blood linezolid concentrations in methicillin-resistant staphylococcus aureus (MRSA) infection; an open-label, non-randomized study |
Date of disclosure of the study information | 2010/10/04 |
Last modified on | 2023/05/30 13:11:05 |
A relationship between linezolid-induced myelosuppression and blood linezolid concentrations in methicillin-resistant staphylococcus aureus (MRSA) infection; an open-label, non-randomized study
A relationship between linezolid-induced myelosuppression and blood linezolid concentrations in MRSA infection
A relationship between linezolid-induced myelosuppression and blood linezolid concentrations in methicillin-resistant staphylococcus aureus (MRSA) infection; an open-label, non-randomized study
A relationship between linezolid-induced myelosuppression and blood linezolid concentrations in MRSA infection
Japan |
MRSA infection
Infectious disease | Orthopedics | Intensive care medicine |
Others
NO
To investigate a relationship between linezolid-induced myelosuppression and serum linezolid concentrations, blood sample are assayed after administration of linezolid intravenously or orally in MRSA infections.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
A relationship between linezolid-induced myelosuppression and serum linezolid concentrations
Blood concentration-time profile of major metabolites in patients
Urinary excretion amounts of linezolid and major metabolites in patients
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
All patients receive a dose of 600 mg linezolid every 12h orally or intravenously, and their blood samples are assayed.
20 | years-old | <= |
Not applicable |
Male and Female
1) age, 20 years or higher
2) MRSA infections, including suspicions
3) Inpatients and outpatients in our hospital
4) Prescribed blood sampling were available
5) gave their or their relatives' written informed consent
1) history of hypersensitivity to ZYVOX
2) pregnancy, parturition or lactation
3) other situation that doctor decides
50
1st name | |
Middle name | |
Last name | Yoshimichi Sai |
Kanazawa University Hospital
Department of Pharmacy
13-1 Takara-machi, Kanazawa 920-8641
076-265-2000
sai-ys@staff.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshimichi Sai |
Kanazawa University Hospital
Department of Pharmacy
13-1 Takara-machi, Kanazawa 920-8641
076-265-2046
sai-ys@staff.kanazawa-u.ac.jp
Kanazawa University Hospital
none
Self funding
NO
2010 | Year | 10 | Month | 04 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000005181
Published
https://pubmed.ncbi.nlm.nih.gov/30459957/
28
Our clinical study indicated that multiple doses of rifampicin (RFP) reduced the dose-normalized trough concentration of linezolid (LZD) at the first assessment day by an average of 65%.
2023 | Year | 05 | Month | 30 | Day |
All participants, who were adults being treated with oral LZD 600 mg every 12 h.
All participants, who were adults being treated with oral LZD 600 mg every 12 h.
The present study included 7 patients in the LZD group and 3 patients in the LZD/RFP group.
none
sex, age, body weight, estimated glomerular filtration rate, C-reactive protein, platelet count, Hb concentration, duration of LZD therapy, total dosage, daily dose,
trough concentration of LZD at the first assessment day during LZD therapy, number of instances of TDM, concomitant drugs received during LZD therapy and success rate
Completed
2010 | Year | 09 | Month | 09 | Day |
2010 | Year | 09 | Month | 09 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 12 | Month | 19 | Day |
2010 | Year | 10 | Month | 04 | Day |
2023 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005181
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |