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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

Results posted on

2018-06-06

Participant Flow

Participant milestones

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

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=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.3 years n=5 Participants	13.7 years n=7 Participants	14.5 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Maximum Plasma Concentration (Cmax)	66.5 mg/L Interval 45.1 to 97.8	42.4 mg/L Interval 36.1 to 46.5

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose

Population: 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

Outcome measures
Measure	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	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
Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)	708 mg∙hr/L Interval 525.0 to 944.0	388 mg∙hr/L Interval 323.0 to 429.0

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)	1051 mg∙hr/L Interval 804.0 to 1412.0	557 mg∙hr/L Interval 454.0 to 617.0

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)	1477 mg∙hr/L Interval 1142.0 to 2127.0	734 mg∙hr/L Interval 579.0 to 874.0

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Volume of Distribution at Steady State (Vss)	6.38 L Interval 6.23 to 6.49	5.89 L Interval 4.68 to 6.99

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Elimination Rate Constant (Ke)	0.00848 hr-1 Interval 0.00848 to 0.00848	0.0053 hr-1 Interval 0.00358 to 0.00777

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Total Drug Clearance (CLtotal)	170 mL/hr Interval 143.0 to 208.0	177 mL/hr Interval 150.0 to 221.0

PRIMARY outcome

Timeframe: 0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose

Population: 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

Outcome measures
Measure	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	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
Drug Clearance Due to Dialysis (CLdialysis)	21 mL/hr Interval 18.0 to 23.0	670 mL/hr Interval 646.0 to 690.0

Adverse Events

Daptomycin Peritoneal Dialysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Daptomycin Hemodialysis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 405-271-2859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place