Status:
COMPLETED
Perioperative Tissue Penetration of Antimicrobials in Infants
Lead Sponsor:
Duke University
Conditions:
Bowel Dysfunction
Eligibility:
All Genders
Up to 2 years
Brief Summary
This study aims to define the pharmacokinetic (PK) properties of a commonly used antibiotic to treat cIAI, metronidazole, in the intestinal wall tissue of healthy infants undergoing intestinal surgery...
Detailed Description
This is a single center pilot pharmacokinetic (PK) study to concomitantly measure antibiotic concentrations in the plasma and the intestinal wall of healthy infants undergoing intestinal surgery. Met...
Eligibility Criteria
Inclusion
- Age 0 to 2 years at enrollment
- Written informed consent provided by a parent or legal guardian
- Scheduled to undergo elective intestinal operation for the removal of non-infected bowel
- Sufficient intravascular access to complete the study procedures
Exclusion
- Prior treatment with metronidazole for any dose during the 72 hours prior to study drug administration.
- Patients with active inflammatory or infectious conditions of the bowel such as inflammatory bowel disease, Hirschprung's disease in the portion of bowel to be excised, diverticular disease, cancerous or pre-cancerous lesions, colitis, enteritis, ulcerative disease, Meckel's diverticulum, celiac disease, and irritable bowel syndrome.
- Renal dysfunction defined as serum creatinine \>2 mg/dL at enrollment
- Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
- Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04299867
Start Date
July 15 2020
End Date
April 25 2022
Last Update
November 10 2025
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710