Pharmacokinetics and Safety of Ertapenem in the Postpartum Period
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/1/2014 |
| Start Date: | March 2012 |
| End Date: | September 2014 |
| Contact: | Avinash Patil Patil, MD |
| Phone: | 919-681-5220 |
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.
ertapenem in women with suspected serious infections less than 42 days from the delivery of
their infant.
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.
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.
Inclusion Criteria:
- 18 years of age or older at the time of enrollment.
- Postpartum period < 42 days at the time of enrollment.
- Sufficient venous access to permit administration of study medication.
- 2 clinical signs of postpartum endometritis:
- Oral body temperature of > 101oF at any time, or a temperature of 100.4 on two
occasions 6 hours apart.
- Maternal tachycardia that parallels the temperature.
- Uterine tenderness
- Purulent vaginal discharge
- Findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess,
bowel obstruction, necrosis of the lower uterine segment.
Exclusion Criteria:
- History of previous hypersensitivity reactions to beta lactams.
- Receiving valproic acid or divalproex sodium.
- Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation.
- Subject with a medical condition that, in the opinion of the investigator, would
interfere with the pharmacokinetic evaluation of the medication, place the subject at
an unacceptable risk of injury, or render the subject unable to meet the requirements
of the protocol.
- Previous participation in the study.
- Exposure to ertapenem in the week prior to the study
We found this trial at
1
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