Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns. (DurATi-n)
Early-Onset Neonatal Sepsis, Antibiotic Side Effect
About this trial
This is an interventional treatment trial for Early-Onset Neonatal Sepsis focused on measuring neonatal, early-onset, infection, antibiotic
Eligibility Criteria
Inclusion Criteria:
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000
- Probable or possible infection according to the structured infection risk assessment
- Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment
- Negative blood culture after 48 hours
Exclusion Criteria:
- Infants with positive blood culture
- Blood culture volume prior to antibiotics of < 0.2 ml
- Site-specific infection as for example, meningitis or osteomyelitis
- Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment
Sites / Locations
- Ulrikka NygaardRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Individualized treatment duration
Standard treatment duration
Antibiotic treatment will be discontinued when both of the following two criteria are fulfilled: The infant has had 24 hours without clinical symptoms of infection, after systematic clinical evaluation by a neonatologist. Clinical symptoms specified in Table 1. CRP is < 30 mg/l. If CRP is > 30 at the time when the infant has been symptom-free for 24 hours, CRP will be assessed once every 24 -48 hours and antibiotics will be stopped when CRP < 30.
Standard treatment duration is seven days.