Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

NCT02087566 | Completed DMC

• 1 other identifier: LZDPPT6
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Renal Failure; Impaired Renal Function

Keywords

Linezolid; Pharmacokinetics; Haemodialysis; Dosing adjustment; Eligible subjects were classified into three groups depending on their 24-h urinary creatinine clearance (CLcr) values or HD status.; Group 1, included 6 healthy subjects with normal renal function (CLcr ˃80 ml/min);; Group 2, included 6 patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine);; Group 3, included 6 patients on long term haemodialysis (minimum period of dialysis was 40 month while maximum period were 130 month)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Administration of linezolid to 6 healthy volunteers

OTHER

Administration of linezolid to 6 healthy volunteers {six healthy subjects with normal renal function (CLcr ˃80 ml/min)}

Drug: 600 mg linezolid

Administration of linezolid to 6 acute renal failure patients

OTHER

Administration of linezolid to 6 acute renal failure patients {(six patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine)}

Drug: 600 mg linezolid

Administration of linezolid to 6 ESRD patients

OTHER

Administration of linezolid to 6 end-stage renal disease (ESRD) patients during an intra-dialytic period (on-dialysis): 6 patients on long term HD (minimum period of dialysis was 40 month while maximum period were 130 month) with an ideal body weight of \>60 kg (calculated as {height (cm) -100}×0.9) and a body mass index between 20 and 26 kg/m2 (calculated as {weight (kg)/height (m2)}).

Drug: 600 mg linezolid

Interventions

600 mg linezolid DRUG

Administration of linezolid to 6 ESRD patients; Administration of linezolid to 6 acute renal failure patients; Administration of linezolid to 6 healthy volunteers

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Pharmacy-Damanhour University

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 14, 2014

Record last verified: 2014-03