Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-30 @ 5:48 PM
Study NCT ID:
NCT01587495
Status:
TERMINATED
Last Update Posted:
2015-05-20
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
Sponsor:
Daniel Benjamin
Organization:
Study Overview
Official Title:
Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study terminated due to low subject accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.
Detailed Description:
Ertapenem has received FDA approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. The physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. The objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. This is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. Subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the Duke University Hospital Labor \& Delivery Unit. Each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. Descriptive statistics for the subjects will be calculated. The appropriate non-compartmental pharmacokinetic parameters will be computed, including AUC24, AUCss, Cmax, CL, Vss, t1/2. All subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. Nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: