CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 511 enrolled
Drug / intervention
PCT dosageprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03730636
NCT03730636N/ACompleted
CompareCT.gov

Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate

Assistance Publique - Hôpitaux de Paris·interventional·Posted Nov 5, 2018·Updated Sep 12, 2025

In Brief

A clinical study evaluating PCT dosage for Sepsis. Completed, enrolled 511 participants across 1 site.

Detailed Summary

The duration of antibiotic (ATB) therapy in late onset sepsis (LOS) of the neonate is currently not based on scientific data. The current PROABIS trial will study the use of a biological marker, procalcitonin (PCT), to guide ATB therapy duration in neonates with LOS. Our hypothesis is that the use of procalcitonin guidance can reduce of 30% the duration of ATB treatment without increasing recurrence of infection and mortality.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartFeb 15, 2019
Primary CompletionMar 7, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.7 years ago

Interventions

PCT dosageprocedure

Measurement of PCT concentration will be performed every two days and the ATB therapy will be stopped when PCT level reaches a value equal or below 0.5ng/mL.