MedTrace Logo

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

NCT05329701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Early-Onset Neonatal Sepsis
  • Antibiotic Side Effect

Interventions

OTHER

Individualized treatment duration strategy

As listed under arm description.

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • University of Copenhagen

    collaborator OTHER

  • Ulrikka Nygaard

    lead OTHER

Principal Investigators

  • Emma Malchau Carlsen, MD, PhD · Department of Neonatology, Rigshospitalet, Copenhagen, Denmark

  • Tine Brink Henriksen, MD, Prof · Department of Neonatology, Skejby Sygehus, Aarhus, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2025-04-05
Completion
2025-08-10

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329701 on ClinicalTrials.gov