Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to:

1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).

2. Determine urine, HD and PD clearance of daptomycin.

Clinical Trial Description

Infectious and sepsis events are one of the most common complications in children with chronic kidney disease. The incidence is highest in children with an access for dialysis, especially in those with catheters. Staphylococcal species account for more than 50% of access infections (ranging from 58-77%). Failure to clear the infection results in loss of dialysis access.

Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus, and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown.

Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01012089
Study type	Interventional
Source	University of Oklahoma
Contact
Status	Completed
Phase	N/A
Start date	November 2009
Completion date	April 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated	`NCT04043026` - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed	`NCT05318014` - Low-protein Formula Supplements in Chronic Kidney Disease	N/A
Active, not recruiting	`NCT06071065` - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients	N/A
Completed	`NCT02878317` - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting	`NCT06039254` - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function	Phase 1
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed	`NCT02875886` - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease	Phase 4
Completed	`NCT02896309` - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity	N/A
Completed	`NCT02756520` - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed	`NCT02836574` - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease	Phase 2
Withdrawn	`NCT02885545` - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial	Phase 4
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Active, not recruiting	`NCT02483039` - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization	N/A
Completed	`NCT02992548` - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease	Phase 4
Terminated	`NCT02543177` - Optimised Procedure in Patients With NSTEMI and CKD	N/A
Completed	`NCT02369549` - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease	Phase 3
Recruiting	`NCT02205944` - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes	N/A
Active, not recruiting	`NCT02231138` - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease	Phase 4