Perioperative Tissue Penetration of Antimicrobials in Infants

CompletedOBSERVATIONAL
Enrollment

23

Participants

Timeline

Start Date

July 15, 2020

Primary Completion Date

March 26, 2022

Study Completion Date

April 25, 2022

Conditions
Bowel Dysfunction
Interventions
PROCEDURE

Bowel Surgery with Metronidazole

"Metronidazole will be given per standard of care prior to incision. Intraoperative plasma samples will be obtained from pre-existing vascular access catheters at end of bolus, 30, 60, 90 minutes, at time of intestinal excision(s), and at the end of the case in ethylenediaminetetraacetic acid microcontainers, exceeding no more than approximately 5 mL total.~At the time of intestinal excision, the surgeon will cut at least 500 mg of intestine from the specimen, ensuring all layers of bowel are included. If more than one intestinal sample is taken during the surgery, such as in the case of multiple strictures removed, each sample will be obtained and labeled appropriately."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER