Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate

NCT03730636 | Completed DMC

• 2 other identifiers: P170928J2018-AO1396-49
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Keywords

Late Onset Sepsis (LOS); antibiotic therapy duration; procalcitonin (PCTR)

Outcome Measures

Primary Outcomes (1)

• Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy

  Number of days between start and end of treatment, including treatment of the recurrence, if any

  up to 28 days

Secondary Outcomes (8)

• Non-inferiority of the PCT-guided ATB strategy to usual strategy on mortality at 28 days following randomization

  28 days

• Non-inferiority of the PCT-guided ATB strategy to usual strategy on recurrence of infection within 72 hours after ending ATB therapy.

  28 days

• Description on the total number of assumed or proven bacterial infections within the 28 days following randomization.

  28 days

• To compare the cumulative dose of received ATB treatment (mg/kg).

  Day 28

• To describe the bacteriological epidemiology of LOS

  28 days

Study Arms (2)

PCT-guided strategy

EXPERIMENTAL

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.

Procedure: PCT dosage

Usual practice (control group)

NO INTERVENTION

Management of LOS and treatment is based on the attending clinician's practice and according to the usual practice.

Interventions

PCT dosage PROCEDURE

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.

PCT-guided strategy

Eligibility Criteria

• Age: 96 Hours - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• 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,
• Affiliation to a social security system (recipient or assign).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Neonatology Bretonneau Hospital

Paris, Tours, 37044, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Delphine MITANCHEZ, PU-PH

  Department of Neonatology Bretonneau Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: February 15, 2019
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: September 12, 2025

Record last verified: 2024-03

Locations

FR (1)