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NCT04299867 · ClinicalTrials.gov registry record
Perioperative Tissue Penetration of Antimicrobials in Infants
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 21
- Enrollment target
NCT04299867 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 21 participants.
The verdict
NCT04299867 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study 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 to optimize intestinal wall penetration of antibiotics in infants. Metronidazole will be given at standard of care intravenous loading dose of 30 mg/kg 15 minutes prior to incision, with a maximum dose of 2g. 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, and at the end of the case in ethylenediaminetetraacetic acid microcontainers, exceeding no more than 5mL total.
Interventions
- PROCEDURE Bowel Surgery with Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-07-15 |
| Est. Completion | 2022-04-25 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04299867
The ClinicalTrials.gov registry entry for NCT04299867 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bowel Surgery with Metronidazole is the first listed.
NCT04299867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04299867 about?
NCT04299867 is a clinical study titled "Perioperative Tissue Penetration of Antimicrobials in Infants". 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 to optimize intestinal wall penetration of antibiotics in infants. Metronidazole will be given at s...
What is the current status of trial NCT04299867?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2020-07-15. Estimated completion is 2022-04-25.
What interventions are being tested in trial NCT04299867?
The interventions under investigation include: Bowel Surgery with Metronidazole (PROCEDURE).
Who is sponsoring clinical trial NCT04299867?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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