Trial Outcomes & Findings for Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease (NCT NCT01012089)
NCT ID: NCT01012089
Last Updated: 2018-06-06
Results Overview
COMPLETED
NA
6 participants
0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose
2018-06-06
Participant Flow
Participant milestones
| Measure |
Daptomycin
Daptomycin: Daptomycin IV 5 mg/kg one time dose
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease
Baseline characteristics by cohort
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Daptomycin: Daptomycin IV 5 mg/kg one time dose to patient receiving intermittent hemodialysis on MWF
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Daptomycin: Daptomycin IV 5 mg/kg one time dose to patient receiving continuous cycling peritoneal dialysis
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
15.3 years
n=99 Participants
|
13.7 years
n=107 Participants
|
14.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
42.4 mg/L
Interval 36.1 to 46.5
|
66.5 mg/L
Interval 45.1 to 97.8
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)
|
388 mg∙hr/L
Interval 323.0 to 429.0
|
708 mg∙hr/L
Interval 525.0 to 944.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)
|
557 mg∙hr/L
Interval 454.0 to 617.0
|
1051 mg∙hr/L
Interval 804.0 to 1412.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)
|
734 mg∙hr/L
Interval 579.0 to 874.0
|
1477 mg∙hr/L
Interval 1142.0 to 2127.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
5.89 L
Interval 4.68 to 6.99
|
6.38 L
Interval 6.23 to 6.49
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Elimination Rate Constant (Ke)
|
0.0053 hr-1
Interval 0.00358 to 0.00777
|
0.00848 hr-1
Interval 0.00848 to 0.00848
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
The rate at which a drug substance is removed from the body
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Total Drug Clearance (CLtotal)
|
177 mL/hr
Interval 150.0 to 221.0
|
170 mL/hr
Interval 143.0 to 208.0
|
PRIMARY outcome
Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dosePopulation: The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin
The rate at which a drug substance is removed from the body due to dialysis therapy
Outcome measures
| Measure |
Daptomycin Hemodialysis
n=3 Participants
Pediatric hemodialysis patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a hemodialysis session
|
Daptomycin Peritoneal Dialysis
n=3 Participants
Pediatric peritoneal patients who received a one time dose of Daptomycin IV 5 mg/kg administered prior to a peritoneal dialysis session
|
|---|---|---|
|
Drug Clearance Due to Dialysis (CLdialysis)
|
670 mL/hr
Interval 646.0 to 690.0
|
21 mL/hr
Interval 18.0 to 23.0
|
Adverse Events
Daptomycin Peritoneal Dialysis
Daptomycin Hemodialysis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Teresa Lewis Pharm D
University of Oklahoma College of Pharmacy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place