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Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate

NCT03730636 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

PCT dosage

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Delphine MITANCHEZ, PU-PH · Department of Neonatology Bretonneau Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
96 Hours
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2023-03-07
Completion
2023-03-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03730636 on ClinicalTrials.gov