Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

Renal Failure Clinical Trial

— LZDPPT6  

Official title:

Single-Dose Linezolid Pharmacokinetics In Critically Ill Patients With Impaired Renal Function Especially Chronic Haemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087566
• Other study ID #: LZDPPT6
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: March 13, 2014
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Renal failure patients were treated with linezolid (LZD) for proven or suspected infections by multiresistant Gram-positive cocci. The aim of this study is to determine if dose adjustment of LZD is needed as a function of renal impairment or not, especially that a significant component of LZD is eliminated unchanged in urine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy subjects with normal renal function (CLcr ?80 ml/min);

• Patients with acute renal failure (RF) (30?CLcr?80 ml/mine)

• Patients on long term HD with an ideal body weight of >60 kg and a body mass index between 20 and 26 kg/m2

• Passed all the screening parameters

• Free of any drug exposure known to interfere with the pharmacokinetics or assay of linezolid for at least 10 days prior to the study

• Able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

Had a history of clinically significant organ dysfunction other than renal disease or those diseases associated with renal disease (as in case of acute RF or ESRD patients) Had physical examination or laboratory test results outside the inclusion such as; sitting systolic BP (SBP) of >140 or <100 mmHg, diastolic BP (DBP) > 90 or <60mm Hg (as in case of healthy volunteers and acute RF patients), or a pulse rate of > 95 or < 50 beats/min at screening; history of orthostatic hypotension; history of serious intolerance, allergy or sensitivity to linezolid ; history of blood dyscrasias; history of alcohol, smoking, or drug abuse; donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study; unable to tolerate vein puncture and multiple blood samplings; any surgical/medical condition that might alter the absorption, distribution, metabolism, excretion of linezolid ; or can't follow instructions, according to the investigator's opinion.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Impaired Renal Function
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• 600 mg linezolid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.	Participants will be followed for the duration of study, an expected average of 6 weeks.	Yes