PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS (PROPOSE)

March 21, 2023 updated by: Carlo Dani, University of Florence

PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial

The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS).

The main question it aims to answer is:

• Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH >3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.

Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight <1500 g will be eligible for enrollment in the study.

Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.

Exclusion Criteria:

  • Risk factors for EOS:

    • maternal GBS colonization without adequate prophylaxis;
    • clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°C or a temperature of 38.0-38.9°C that persists for >30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia;
    • pre-labor rupture of membranes (ROM) >1 h before delivery.
  • Surgery within the first week of life,
  • major congenital malformations,
  • chromosomal syndromes,
  • inherited metabolic disorders,
  • fetal hydrops

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antibiotic prophylaxis for EOS
Procedure: Antibiotic prophylaxis for EOS
Infants will receive antibiotic prophylaxis for EOS.
Experimental: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS
Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival without major morbidities.
Time Frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Participants will be monitored for the duration of hospital stay which is an average of 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual components of the composite primary outcome will be regarded as secondary outcomes.
Time Frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Occurrence of IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Participants will be monitored for the duration of hospital stay which is an average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPOSE02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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