Can a 24-hour linezolid regimen replace the current 12-hour regimen as the standard of care?
Design
A controlled, parallel-group, non-blinded, randomized, phase 3 clinical trial on 40 patients. Excel software was used for randomization.
Settings and conduct
This study will be conducted in the intensive care unit of Sina Hospital in Tehran, with linezolid administered in two forms: continuous infusion and every 12 hours in patients with reduced kidney function. Blood samples will be taken from the patients within 48 hours of the study to check drug levels.
Participants/Inclusion and exclusion criteria
Age over 18 years; suspected or proven Gram-positive infection for which your doctor has prescribed intravenous linezolid; renal filtration rate less than 40 mL/min
Hemoperfusion and plasmapheresis and dialysis; Hypersensitivity to linezolid or any of the product's excipients; Pregnancy and lactation
Intervention groups
Linezolid is administered in two forms: 24-hour infusion and every 12 hours in two different groups.
Main outcome variables
Percentage ratio when the plasma concentration of the drug is higher than the MIC in patients; review and comparison of AUC/MIC in the studied patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251202068186N1
Registration date:2026-02-17, 1404/11/28
Registration timing:prospective
Last update:2026-02-17, 1404/11/28
Update count:0
Registration date
2026-02-17, 1404/11/28
Registrant information
Name
Mohammadhasan Mirasheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 6264
Email address
mohammadmirasheh30@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-06, 1404/12/15
Expected recruitment end date
2026-10-28, 1405/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study and comparison of the pharmacokinetics of continuous infusion of linezolid versus intermittent dosing in patients with renal failure
Public title
Review of 24-hour linezolid administration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
Fever greater than 37.8°C
Informed consent
Leukocytosis above 10,000 cells per cubic millimeter
Serum lactate above 18 milligram per decilitre
Suspected or proven gram-positive infection for which the treating physician has prescribed intravenous linezolid
Glomerular filtration rate less than 40 milliliter per minute
Exclusion criteria:
Pregnancy and breastfeeding
Patients undergoing hemoperfusion and plasmapheresis
Dialysis
Hypersensitivity to linezolid or any of the product's excipients
• Taking any compound that inhibits the enzyme mono-amine oxidase A or B
Hematological diseases
disseminated intravascular coagulation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be randomly assigned to two groups receiving continuous infusion and intermittent administration in a 1:1 ratio using a random number generator in Excel. We use a simple randomization method and the units of randomization are participants.
Randomization is performed in an unblinded manner.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences
Street address
Second Floor, The Institute Of Pharmaceutical Sciences, Tehran University Of Medical Sciences, 16 Azar Street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2026-02-14, 1404/11/25
Ethics committee reference number
IR.TUMS.TIPS.REC.1404.162
Health conditions studied
1
Description of health condition studied
the pharmacokinetics of continuous infusion of linezolid versus intermittent dosing in patients with renal failure
ICD-10 code
N18.3
ICD-10 code description
Chronic kidney disease, stage 3 (moderate)
Primary outcomes
1
Description
Percentage of time when the plasma concentration of the drug is above the Minimum Inhibitory Concentration patients
Timepoint
Samples were measured at times before starting the drug (time zero), 1.5, 2, 4, 8, 12, 5.13, 24, 5.25, 36 and 48 hours after starting linezolid.
Method of measurement
High Performance Liquid Chromatography Device
2
Description
area under the concentration-time curve
Timepoint
End of sampling
Method of measurement
Concentration-time curve
Secondary outcomes
1
Description
Blood platelet levelدر
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Number per microliter of blood
2
Description
Albumin to lactate ratio
Timepoint
The beginning and end of the study
Method of measurement
Blood albumin and lactate levels
Intervention groups
1
Description
Intervention group: Receiving the Linezolid from Shahid Ghazi Company as a 24-hour continuous infusion at a rate of 50 mg per hour and a loading dose of 600 mg over one hour
Category
Treatment - Drugs
2
Description
Control group: Receiving Linezolid from Shahid Ghazi Company in the form of 600 mg every 12 hours, which is infused for one hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sinai اospital
Full name of responsible person
Mojtaba Mojtahedzadeh
Street address
Sina hospital., before Hassan Abad Square., Imam Khomeini St., Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 6239
Fax
Email
Mohammadmirasheh30@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice President for Research and Technology., 6th Floor., Central University Organization., corner of Qods Street., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rational Drug Prescription Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Mojtahedzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical Care Department., Sina hospital., before Hassan Abad Square., Imam Khomeini Street., Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 6239
Email
mojtahed@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Mojtahedzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmaceutical Care Department., Sina hospital., before Hassan Abad Square., Imam Khomeini Street., Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 6239
Email
mojtahed@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadhasan Mirasheh
Position
Resident
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 732., Alborz Educational Complex., After Azizolleh Zare Street., End of Ashrafi Esfahani Highway., Tehran
City
Tehran
Province
Tehran
Postal code
1469883967
Phone
+98 21 4486 6264
Fax
Email
mohammadmirasheh30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data on patient characteristics such as age, gender, and medications, as well as information on the main and secondary outcomes of the intervention after de-identifying the individuals.
When the data will become available and for how long
The start of the access period after the end of the study and printing of the results
To whom data/document is available
Allowing access to researchers of academic and hospital institutions
What processes are involved for a request to access data/document
First, the applicant must send the documents that he requests access to by e-mail, stating the reason and details, to the researchers of this project (given in the previous box), and then after reviewing and consulting, these documents will be sent to him.