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

Ulrikka Nygaard488 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

488

Conditions

Early-Onset Neonatal Sepsis Antibiotic Side Effect

Interventions

Individualized treatment duration strategyOTHER

As listed under arm description.

Eligibility

Sex: ALLMin age: 1 HourMax age: 72 Hours

Medical Language ↔ Plain English

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

Locations (1)

Ulrikka Nygaard

Copenhagen, Denmark

Outcomes

Primary Outcomes

Readmission due to infection.

Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment \> 72 hours

Time frame: From 1-21 days after end of first course of antibiotic treatment.

Death

Death of any cause

Time frame: From 1-21 days after end of first course of antibiotic treatment.

Total use of antibiotics

Use of antibiotics (in hours)

Time frame: From initiation of antibiotics and the next 28 days.

Secondary Outcomes

C-reactive protein (CRP)

CRP (mg/l) levels at follow-up

Time frame: CRP measured at follow-up 2 days after initial antibiotic treatment ended

Readmission due to infection within 3 months

Readmission due to infection, defined as symptoms, affected biomarkers and antibiotic treatment \> 72 hours

Time frame: From 1-100 days after first course of antibiotics ended.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.