Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate (NCT03730636) | Clinical Trial Compass
CompletedNot Applicable
Procalcitonin and Duration of AntiBiotherapy In Late Onset Sepsis of Neonate
France511 participantsStarted 2019-02-15
Plain-language 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.
Who can participate
Age range96 Hours – 1 Month
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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,
* Weight at the inclusion ≥ 700 g,
* 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,
* Written informed consent signed by both parents (in the absence of one of the two parents the day of inclusion, the new born can be included with the signature of only one parent.The second parent must give oral consent and sign the consent form as soon as possible "before day 28"),
* Affiliation to a social security system (recipient or assign).
Exclusion Criteria:
* 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 disch…
What they're measuring
1
Efficacy of the PCT guided ATB strategy on the duration of ATB treatment compared to usual ATB strategy