Pharmacokinetics and Safety of Ertapenem in the Postpartum Period

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Benjamin
• Treatments: Ertapenem

Criteria

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