Status:
RECRUITING
Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.
Lead Sponsor:
Ulrikka Nygaard
Collaborating Sponsors:
Innovation Fund Denmark
University of Copenhagen
Conditions:
Early-Onset Neonatal Sepsis
Antibiotic Side Effect
Eligibility:
All Genders
1-72 years
Phase:
PHASE4
Brief Summary
A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven...
Detailed Description
There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of indi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 18 2028
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT05329701
Start Date
April 22 2022
End Date
April 18 2028
Last Update
June 30 2022
Active Locations (1)
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1
Ulrikka Nygaard
Copenhagen, Denmark, 2100