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Tiny patients, big questions: antibiotic levels in infant bowel surgery

NCT ID NCT04299867

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how the antibiotic metronidazole spreads into the intestinal tissue of 21 infants (ages 0-2) during planned bowel surgery. Researchers took blood and tissue samples at several time points to measure drug levels. The goal is to find the best dose to prevent infections after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metronidazole
What this could lead to
If successful, this could help doctors give the right dose of metronidazole to infants during bowel surgery to prevent infections.
What could go wrong
This is a small, early study with only 21 infants, so results may not apply to all babies. It measures drug levels, not whether infections are actually prevented.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

21 people

The number who actually took part.

Started

Jul 2020

Finished

Apr 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children \< 2 years of age undergoing intestinal surgery

Ages

0 to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 0 to 2 years at enrollment 2. Written informed consent provided by a parent or legal guardian 3. Scheduled to undergo elective intestinal operation for the removal of non-infected bowel 4. Sufficient intravascular access to complete the study procedures Exclusion Criteria: 1. Prior treatment with metronidazole for any dose during the 72 hours prior to study drug administration. 2. 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. 3. Renal dysfunction defined as serum creatinine \>2 mg/dL at enrollment 4. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment 5. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

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Conditions

The condition(s) this trial relates to.

bowel dysfunction intestinal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bowel dysfunction

Contacts and locations

Locations

  • Duke University Health System

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.