Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.

Launched by ULRIKKA NYGAARD · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how long newborns with early-onset infections should receive antibiotics. Currently, most newborns are treated with antibiotics for a standard duration of seven days, even if their infection tests come back negative. The trial aims to see if shorter, individualized treatment can be just as effective and may help reduce the side effects of antibiotics.

To participate in the trial, newborns must be at least 35 weeks old and weigh 2000 grams or more. They should show signs of infection but have negative blood culture results after 48 hours of treatment. If eligible, participants will be randomly assigned to either continue the standard seven-day treatment or receive a shorter, tailored course of antibiotics. The goal is to find out which approach is better for the health of these infants. This study is currently recruiting and is taking place across multiple hospitals, so there is a good chance for families to find a participating location nearby.

Gender

ALL

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