Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy

NCT05350813 | Recruiting

• 2 other identifiers: RC31/21/03342022-A00246-37
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 7

Brief Summary

In this randomized controlled open-label trial, conducted in 7 French Pediatric and Neonatal Intensive Care Units (ICUs), investigator team hypothesize that the use of a procalcitonin (PCT)-guided algorithm to discontinue antibiotic treatment will decrease antibiotic duration in critically ill children treated for a suspected or proven bacterial infection. Two hundred and ninety-six eligible patients will be randomly assigned in two groups: either PCT-guided or standard-of-care antibiotic discontinuation, and monitored over 28 days, until the end of their hospitalization, or up to the end of antibiotic treatment for bacterial infection recurrence occurring up to 28 days after the day of randomization.

Conditions

Bacterial Infections

Keywords

procalcitonin; Children; Pediatric Intensive Care Unit; Procalcitonin-guided antibiotic therapy; Algorithm

Outcome Measures

Primary Outcomes (1)

• Total duration of antibiotic therapy (in days) for a suspected or proven bacterial infection, including the first episode and recurrences occurring within 28 days following the day of randomization

  Duration of antibiotic therapy (in days) including the length of treatment for recurrences occurring within 28 days following the day of randomization. The duration of antibiotic therapy for the first episode of suspected or proven bacterial infection is the time interval, expressed in days, between the starting time of intravenous antibiotics and the stopping time of the antibiotic therapy (intravenous, intramuscular or oral). The duration of antibiotic therapy for a recurrence of bacterial infection is the time interval, expressed in days, between the starting time of a new antimicrobial therapy (intravenous, intramuscular or oral) covering the initial causative bacteria within 28 days following the day of randomization, and the stopping time of this antibiotic therapy (even if ending after 28 days following the day of randomization).

  month 3 (maximum follow-up period of 3 months)

Secondary Outcomes (12)

• Total duration of broad-spectrum antibiotic therapy in days) for a suspected or proven bacterial infection, including the first episode and recurrences

  month 3 (maximum follow-up period of 3 months)

• Length of Intensive Care Unit stay (in days) from Day 0 (day of randomization)

  month 3 (maximum follow-up period of 3 months)

• Length of hospital stay from Day 0 (day of randomization)

  month 3 (maximum follow-up period of 3 months)

• Recurrence of bacterial infection within 28 days following the day of randomization

  day 28

• All cause mortality at Day 28 (Day 0 = day of randomization)

  day 28

Study Arms (2)

PCT-guided arm

EXPERIMENTAL

Group of patients whose duration of antibiotic therapy will depend on procalcitonin (PCT) plasma levels on days 0 and 1, then on PCT plasma level every 48 hours and on patient clinical evolution evaluated by the fever, the infected organ, and the pSOFA (Pediatric Sequential Organ Failure Assessment) score every day until cessation of antibiotics in hospital or until discharge from hospital if the patient is discharged with an antibiotic treatment.

Procedure: Measurement of the PCT plasma levels

standard-of-care arm

ACTIVE COMPARATOR

A group of patients whose duration of antibiotic therapy will be determined by the type of infection, microbiological findings and clinical, biological and/or radiological course, according to standard practice based on guidelines.

Procedure: Usual practice based on guidelines

Interventions

Measurement of the PCT plasma levels PROCEDURE

antibiotic treatment duration will be based on PCT plasma levels

PCT-guided arm

Usual practice based on guidelines PROCEDURE

antibiotic therapy duration will be determined by the type of infection, microbiological results and clinical, biological and/or radiological evolution, according to the usual practice based on guidelines.

standard-of-care arm

Eligibility Criteria

• Age: 3 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode of suspected or proven community-acquired or nosocomial bacterial infection.
• Written informed consent signed by both parents or legal guardians.
• Affiliated to a social security scheme.
• Parents French-speaking.

You may not qualify if:

• Newborns \<72 hours old.
• Neonates \<37 weeks postmenstrual age.
• Age ≥18 years.
• Pregnant or breastfeeding women.
• Patients with cystic fibrosis.
• Immunocompromised patients including patients with hereditary immunodeficiency, agranulocytosis (neutrophils count \<500/mm3), HIV infection with CD4 count \<200/mm3, sickle cell disease, those who have undergone splenectomy, those who have a history of solid organ or hematopoietic stem cell transplant, those with hemopathy or solid organ tumor treated with chemotherapy, and those on immunosuppressive drugs including systemic corticosteroids taken daily for at least 15 days prior to Day 0.
• Inflammatory situations increasing PCT plasma concentrations in the absence of infection: burns, extracorporeal membrane oxygenation (ECMO), first 48 hours following an open-heart cardiac surgery with cardiopulmonary bypass.
• Infections requiring prolonged antibiotic therapy: infected thrombophlebitis, infective endocarditis, mediastinitis, abscess or empyema (e.g. peritonsillar abscess, retropharyngeal abscess, adenophlegmon, retroauricular abscess, retroorbital abscess, pulmonary abscess, pleural empyema, liver abscess, splenic abscess, brain abscess, subdural empyema, extradural empyema, epidural abscess, intramuscular abscess), necrotizing dermohypodermitis or necrotizing fasciitis, osteomyelitis, osteitis, arthritis, spondylodiscitis, prostatitis, tuberculosis, meningitis except those caused by Haemophilus and Meningococcus, infection on a device excluding intravascular catheter, endotracheal tube, tracheostomy, and urinary catheter.
• Antibiotic for prophylaxis.
• Children previously included in an interventional study in progress.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

CHU Amiens Picardie

Amiens, France

ACTIVE NOT RECRUITING

CHU de Bordeaux

Bordeaux, France

ACTIVE NOT RECRUITING

CHU de Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

CHU de NANTES

Nantes, France

RECRUITING

APHP

Paris, France

ACTIVE NOT RECRUITING

CHU La Réunion

Saint-Denis, France

RECRUITING

University Hospital of Toulouse

Toulouse, 31100, France

RECRUITING

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Romain AMADIEU, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain AMADIEU, MD

CONTACT

053-455-7495; amadieu.r@chu-toulouse.fr

Gwennaëlle ALPHONSA

CONTACT

056-777-1394; alphonsa.g@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 28, 2022
• Study Start: May 2, 2023
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)