NCT05329701

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

Individualized Duration of Antibiotic Treatment in Culture Negative Early Onset Infection in Term Born Newborns: A Nationwide Randomized Controlled Non-inferiority Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: Ulrikka Nygaard · Academic / Other
• Sex: All
• Age: 1 Hour – 72 Hours
• Healthy volunteers: Not accepted

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 days of antibiotic treatment for culture negative early-onset infection in term newborns.

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 individualized treatment duration in early-onset infection. The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.

Conditions

• Early-Onset Neonatal Sepsis
• Antibiotic Side Effect

Interventions

Type	Name	Description
OTHER	Individualized treatment duration strategy	As listed under arm description.

Timeline

• Start date: 2022-04-22
• Primary completion: 2025-04-05
• Completion: 2025-08-10
• First posted: 2022-04-15
• Last updated: 2026-01-12

Locations

1 site across 1 country: Denmark