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Newborn drug dosing study uses leftover blood samples

NCT ID NCT04031183

Knowledge-focused Sponsor: Rennes University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the antibiotic metronidazole works in 171 newborns to find the best dose. Researchers used leftover blood or spinal fluid from routine tests, so no extra pokes were needed. The goal was to make sure enough babies get the right amount to fight infection without side effects.

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

171 people

The number who actually took part.

Started

May 2020

Finished

Aug 2021

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

Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).

Ages

Up to 44 weeks

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: * In case of birth at gestational age ≥ 37 weeks of amenorrhea (SA): inclusion of children of postnatal age \<28 days * In case of birth at a gestational age \<37 SA: inclusion of post-menstrual age children (ie gestational age + post-natal age) \<44 SA 2. Benefiting from metronidazole antibiotic therapy, as part of their routine independent clinical management of the study, whether the targeted infection is suspected or proven 3. Social Security Affiliates 4. No opposition of parents to participation in the study Non-Inclusion Critéria Treatment with metronidazole initiated before arrival in the investigative center (\> 1 dose). Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

Emergencies

As listed by the trial registrant

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

Emergencies

Contacts and locations

Locations

  • CH St Brieuc

    Saint-Brieuc, France

  • CH Vannes

    Vannes, France

  • CHU d'Angers

    Angers, France

  • CHU de Brest

    Brest, France

  • CHU de Rennes

    Rennes, France

  • CHU de Tours

    Tours, France

  • Centre Robert Debré

    Paris, France

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