Actively Recruiting
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
Led by University Hospital, Toulouse · Updated on 2024-09-25
296
Participants Needed
7
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for a suspected or proven bacterial infection
- Written informed consent signed by both parents or legal guardians
- Affiliated to a social security scheme
- Parents French-speaking
You will not qualify if you...
- Newborns under 72 hours old
- Neonates less than 37 weeks postmenstrual age
- Age 18 years or older
- Pregnant or breastfeeding women
- Patients with cystic fibrosis
- Immunocompromised patients including hereditary immunodeficiency, agranulocytosis (neutrophils count <500/mm3), HIV infection with CD4 count <200/mm3, sickle cell disease, history of organ or stem cell transplant, hemopathy or solid organ tumor treated with chemotherapy, or on immunosuppressive drugs including systemic corticosteroids daily for at least 15 days prior to Day 0
- Inflammatory conditions raising PCT levels without infection such as burns, ECMO, or within 48 hours after open-heart cardiac surgery with cardiopulmonary bypass
- Infections requiring prolonged antibiotic therapy such as infected thrombophlebitis, infective endocarditis, mediastinitis, abscesses, necrotizing infections, osteomyelitis, arthritis, prostatitis, tuberculosis, meningitis (except Haemophilus and Meningococcus), device infections excluding intravascular catheter, endotracheal tube, tracheostomy, and urinary catheter
- Antibiotic use for prophylaxis
- Children previously included in another ongoing interventional study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
CHU Amiens Picardie
Amiens, France
Active, Not Recruiting
2
CHU de Bordeaux
Bordeaux, France
Active, Not Recruiting
3
CHU de Clermont Ferrand
Clermont-Ferrand, France
Actively Recruiting
4
CHU de NANTES
Nantes, France
Actively Recruiting
5
APHP
Paris, France
Active, Not Recruiting
6
CHU La Réunion
Saint-Denis, France
Actively Recruiting
7
University Hospital of Toulouse
Toulouse, France, 31100
Actively Recruiting
Research Team
R
Romain AMADIEU, MD
CONTACT
G
Gwennaëlle ALPHONSA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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