Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Completed · Not applicable
Conditions studied: Chronic Kidney Disease, Bacterial Infection
In brief
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.
Key facts
- Study ID
- NCT01012089
- Run by
- University of Oklahoma
- People needed
- 6
- Starts
- 2009-11-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2018-06-06
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
- In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
- Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
- Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic
You may not qualify if…
- Patients > 17 years of age
- Patients < 12 years of age
- Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
- Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
- Having used daptomycin in the 30 days preceding study entry
- Participating in any experimental procedure in the 30 days preceding study
- A history of muscular disease or neurological disease
- Baseline creatine phosphokinase (CPK) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 IU/L)
- Hemoglobin < 9 g/dl
- Hemodynamic instability within 72 hours before study enrollment
- Female subjects with a positive pregnancy test or failure to take a pregnancy test
Where it is running
- The Children's Hospital at the University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.