Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02087566
Other study ID # LZDPPT6
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02763410 - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT03292029 - Pilot Medical Evaluation of the T50 Test N/A
Suspended NCT04589065 - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device) N/A
Completed NCT03806998 - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure Phase 3
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT02116270 - Accelerated Immunosenescence and Chronic Kidney Disease N/A
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Completed NCT01388270 - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis Phase 4
Completed NCT01187953 - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacroâ„¢ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx Phase 3
Completed NCT00966615 - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01008631 - The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers N/A
Completed NCT00765661 - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients Phase 2
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Recruiting NCT00470769 - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2