Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)

NCT ID: NCT02087566

Last Updated: 2014-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Administration of linezolid to 6 healthy volunteers

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

Group Type: OTHER

600 mg linezolid

Intervention Type: DRUG

Administration of linezolid to 6 acute renal failure patients

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

Group Type: OTHER

600 mg linezolid

Intervention Type: DRUG

Administration of linezolid to 6 ESRD patients

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)}).

Group Type: OTHER

600 mg linezolid

Intervention Type: DRUG

Interventions

600 mg linezolid

Intervention Type: DRUG

Eligibility Criteria

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.

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• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Sally Helmy, PhD, CPHQ

Faculty of Pharmacy-Damanhour University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LZDPPT6

Identifier Type: -

Identifier Source: org_study_id