Comparing two antibiotic regimens for the treatment of late onset sepsis in neonates

Phase 4

Completed

• Conditions: ate Onset Sepsis; Preterm Birth; Late Onset Sepsis; Infection - Studies of infection and infectious agents; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12618000073202
• Lead Sponsor: John Hunter Childrens Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Study Completion: 2020-07-02
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Signed, written informed consent by a parent or a legal guardian
Infants <29 weeks gestation at birth
Baby starting treatment for an episode of suspected LOS
Postnatal age more than 72 hours and less than term corrected gestational age (at time of suspected LOS).

Exclusion Criteria

Presence of major congenital malformation(s) or chromosomal abnormalities
Contraindications for either antibiotic regimen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is treatment failure. This is defined as worsening or not improving clinical status that leads to change of the initial antibiotic treatment within 48 hours as reviewed by the attending Neonatologist for one of the following reasons: <br>1. Worsening or not improving clinical status >12 hours after antibiotics were started<br>2. Progression from sepsis to severe sepsis or septic shock<br>3. Fluid and catecholamine refractory shock[Primary Timepoint 1 will be after 48 hours of treatment with antibiotics, to determine if treatment failure has occurred (i.e. whether antibiotics have been changed) ]

Secondary Outcome Measures

Name	Time	Method
one[NONE]