Neonatal Antimicrobial Resistance and Outcome

Neonatal Infection Clinical Trial

— neoAMRO  

Official title:

Neonatal Antimicrobial Resistance and Outcome (neoAMRO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743816
• Other study ID #: 2019.0048
• Status: Recruiting
• Start date: July 30, 2019
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2023
• Source: St George's, University of London
• Contact: Sana Ibrahim, BSc
• Phone: 02087255382
• Email: sibrahim[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a multicentre observational study involving NNUs across the UK. Study personnel (Neonatologists and research Nurses) from these NNUs will identify eligible babies in whom a positive culture has been obtained.

This study will help identify the infections leading to death in babies on UK neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

Description:

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database. Over 30 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire. Denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Through our study we aim to understand and describe better those infections and risk factors that lead to death. The case-control study will enable us to determine if gaps in optimal management, such as the wrong antibiotic or the wrong dose, are associated with poor outcomes. We can then translate such information into practice and develop / improve clinical guidance in order to improve outcomes.

For the purpose of this study, we will request information on the baby's status (alive/died/not known) at 28 days after the positive culture was obtained. If the baby is alive, then this baby becomes eligible as a control. If the baby has died, then further details will be sought including the date of death and whether death was attributed to the infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: February 29, 2024
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 28 Days to 12 Months

Eligibility

Inclusion criteria:

• Infants on participating NNUs who have an episode of infection with a positive culture.

Related Conditions & MeSH terms

• Infections
• Neonatal Infection

Locations

Country	Name	City	State
United Kingdom	St George's University of London	London

Sponsors (2)

Lead Sponsor	Collaborator
St George's, University of London	Antibiotic Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying infections	To identify the infections leading to death in babies on UK neonatal units	5 years
Primary	Clinical characteristics	To define the clinical characteristics of babies dying from infections	5 years
Primary	Management of infections	To describe the management of babies dying from infections with a specific focus in their antimicrobial treatment and the antimicrobial resistance profiles of the relevant organisms	5 years
Secondary	Comparing bacterial infections	In a case-control study we will assess the hypothesis that babies who die from bacterial infections on neonatal units do so because they receive inappropriate antibiotic management. To do this we will compare babies who die from bacterial infections with babies who survive bacterial infections on a range of factors including appropriateness, dose and timeliness of antibiotic use.	5 years