Trial Outcomes & Findings for Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis (NCT NCT00939952)

Results Overview

Population PK

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

12h

Results posted on

2013-02-26

Participant Flow

Patients were recruited from an outpatient dialysis center. Eligible patients were referred to study investigators by social workers or nurses.

All study patients were assigned to receive study drug to explore the pharmacokinetic profile of ertapenem during CAPD. Once enrolled, patients were excluded if they developed infection.

Participant milestones

Participant milestones
Measure	Ertapenem 500 mg IV x1 All patients will receive ertapenem 500 mg IV once.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age Continuous	55.14 years STANDARD_DEVIATION 17 • n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 12h

Population PK

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
Volume of Distribution, Central Compartment (Vc)	2.78 Liters (L) Standard Deviation 062

PRIMARY outcome

Timeframe: 12h

population PK clearance

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
Clearance (CL)	.24 Liters/hour (L/h) Standard Deviation .068

PRIMARY outcome

Timeframe: 12h

1st order intercompartmental rate constant between central and peripheral compartments

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
k12	2.51 h^(-1) Standard Deviation 1.39

PRIMARY outcome

Timeframe: 12h

1st order intercompartmental rate constant from peripheral to central compartment

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
k21	2.03 h^(-1) Standard Deviation 1.04

PRIMARY outcome

Timeframe: 12h

1st order intercompartmental rate constant from central to peritoneal cavity

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
k13	0.082 h^(-1) Standard Deviation .053

PRIMARY outcome

Timeframe: 12h

1st order intercompartmental rate constant peritoneal cavity to central

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
k31	.16 h^(-1) Standard Deviation .074

PRIMARY outcome

Timeframe: 6h

Outcome measures

Outcome measures
Measure	Ertapenem 500 mg IV x1 n=7 Participants All patients will receive ertapenem 500 mg IV once.
Residual Drug in Peritoneal Cavity After 1st Exchange	.64 mg Standard Deviation .43

Adverse Events

Ertapenem 500 mg IV x1

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

Katie Cardone

Albany College of Pharmacy and Health Sciences

Phone: 518-694-7875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60