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Blood test could shorten antibiotic course for newborns with sepsis

NCT ID NCT03730636

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether measuring a blood marker called procalcitonin (PCT) could help doctors decide when to stop antibiotics in newborns with late-onset sepsis. Over 500 newborns were included, and the goal was to reduce antibiotic use by 30% without increasing infection recurrence or death. The approach could lead to shorter treatment and fewer side effects.

What this could mean

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

Active substance
procalcitonin measurement (blood test)
What this could lead to
If successful, this approach could shorten antibiotic treatment in newborns with sepsis, reducing side effects and hospital stays.
What could go wrong
This is a completed trial, but results may not apply to all hospitals or newborns. The marker may not always accurately guide treatment, risking undertreatment.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

511 people

The number who actually took part.

Started

Feb 2019

Finished

Mar 2023

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.

Ages

96 hours to 1 month

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: * Neonates born at 24 or more weeks of gestation, * Aged over 96 hours of life, i.e. from the 5th day of life and less than 45 gestational weeks at diagnosis of assumed or proven LOS, * Weight at the inclusion ≥ 700 g, * Treated by ATB therapy for less than 48 hours, * When the physician decides to continue de empiric ATB treatment beyond the initial 48-h period, * Written informed consent signed by both parents (in the absence of one of the two parents the day of inclusion, the new born can be included with the signature of only one parent.The second parent must give oral consent and sign the consent form as soon as possible "before day 28"), * Affiliation to a social security system (recipient or assign). Exclusion Criteria: * Neonates with non-indication of ATB treatment following the 48h-initial empiric period. * ATB treatment within the 48h before the current episode of infection; except for taking antibiotics for prophylactic purposes (ex: digestive decontamination), pulmonary-targeted treatments for atypical germs and antibiotics by local means (ex.: eye drops). * Patients diagnosed with severe infections (meningitis and/or septic shock) or needing prolonged therapy (ex: endocarditis, bone infection, deep seated infection, abscesses). Septic shock is defined by fluid resistant hypotension requiring vasopressor therapy. * Infections not contracted during the hospitalization in the neonatal period or revealed more than 48 hours after hospital discharge. * Neonates during treatment by extracorporeal membrane oxygenation or extra-corporeal circulation, and within the 72h after the end of the treatment. * Neonates previously included in the Proabis study. * Participation with another interventional study involving human subjects or being in the exclusion period at the end of a previous study involving human subjects.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Neonatology Bretonneau Hospital

    Paris, Tours, 37044, France

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