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New treatment option for Bacterial Infections
Official title Impact of Procalcitonin-guided Algorithm on Early Discontinuation of Antibiotic Therapy
ClinicalTrials.gov ID: NCT05350813
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- Neonates, infants and children hospitalized in Pediatric and Neonatal ICU and receiving intravenous antibiotics for less than 24 hours for an episode...
- Written informed consent signed by both parents or legal guardians.
- Affiliated to a social security scheme.
- Parents French-speaking.
You likely can't join 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...
See the full eligibility criteria
- 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...
- Written informed consent signed by both parents or legal guardians.
- Affiliated to a social security scheme.
- Parents French-speaking.
- 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...
- 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...
- Infections requiring prolonged antibiotic therapy: infected thrombophlebitis, infective endocarditis, mediastinitis, abscess or empyema (e.g. peritonsillar abscess, retropharyngeal abscess, adenophlegmon, retroauricular...
- Antibiotic for prophylaxis.
- Children previously included in an treatment study in progress.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bordeaux, France
- Clermont-Ferrand, France
- Nantes, France
- Paris, France
- Saint-Denis, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 days to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bordeaux, France; Clermont-Ferrand, France; Nantes, France; Paris, France; Saint-Denis, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.