NeoAMR Observational Study in Neonatal Sepsis

August 17, 2020 updated by: Drugs for Neglected Diseases

A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.

Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).

Study Overview

Detailed Description

  1. NeoSEPSIS: Consecutive hospitalized babies with neonatal sepsis will be recruited and followed up until discharge from hospital or death (for a maximum of 28 days). A minimal neonatal sepsis dataset will determine (i) clinical presentations, associated features and risk factors (for example prematurity, SGA (small for gestational age)), (ii) rates of culture-positivity among babies with sepsis, (iii) current empirical treatment approaches (antimicrobials selected, dose, etc) (iv) outcomes of sepsis, including death, need for intensive care interventions and recurrence of sepsis during the follow-up period. Microbiological samples will be taken from sterile sites, blood and CSF, as clinically indicated and will be processed locally.
  2. NeoBSI: Consecutive babies with positive blood/CSF cultures and sepsis will be recruited. Patient inclusion will be based on identification of relevant specified bacteria from blood / CSF cultures. In addition to the data collected for NeoSEPSIS, information will be collected on the isolates and their antimicrobial susceptibility patterns.

Study Type

Observational

Enrollment (Actual)

3202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dhaka, Bangladesh
        • Dhaka Shishu Hospital
      • São Paulo, Brazil
        • FCM da Santa Casa de São Paulo
      • São Paulo, Brazil
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • Beijing, China
        • Beijing Children hospital
      • Beijing, China
        • Beijing Obstetrics and Gynecology Hospital
      • Shenzhen, China
        • Shenzhen Children Hospital
      • Thessaloníki, Greece
        • Hippokration Hospital
      • Mumbai, India
        • King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
      • New Delhi, India
        • Lady Hardinge Medical College
      • Pondicherry, India
        • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
      • Rome, Italy
        • Bambino Gesu Hospital
      • Kilifi, Kenya
        • KEMRI/Wellcome Trust Research Programme
      • Cape Town, South Africa
        • Tygerberg Hospital
      • Johannesburg, South Africa
        • Charlotte Maxeke
      • Johannesburg, South Africa
        • Chris Hani Baragwanath Academic hospital
      • Bangkok, Thailand
        • Queen Sirikit National Institute of Child Health
      • Chang Rai, Thailand
        • Chiang Rai Prachanukroh Hospital
      • Kampala, Uganda
        • Mulago Hospital
      • Hanoi, Vietnam
        • Vietnam National Hospital of Paediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized Babies with significant sepsis

Description

Inclusion Criteria:

  • In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions

    • Age <60 days of age
    • Clinical suspicion of a new episode of sepsis (as defined below)** together with planned treatment with IV antibiotics OR new episode of confirmed bacterial meningitis^ OR new episode of infection in which a Carbapenem-resistant organism (CRO) is isolated from blood culture OR new episode of infection in which a candida species is isolated from blood culture
    • Informed consent from parent / guardian
    • Willingness to provide location information and to be contacted at 28 days from start of antibiotic treatment

Exclusion Criteria:

  • • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached

    • Enrollment in any interventional trial
    • A serious, non-infective co-morbidity (other than prematurity), anticipated to cause death within 72 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Study Clinical Sepsis
Clinical and Antimicrobial Assessments
No intervention-Observational study
Microbiology Sub study
Clinical and Antimicrobial Assessments
No intervention-Observational study
Analysis of Bacterial isolates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: 28 days
To estimate mortality rates in hospitalised infants less than 60 days of age who are being treated for significant sepsis (where significant is defined as presenting with 2 or more of the signs /symptoms listed in the inclusion criteria).
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture
Time Frame: 28 days
The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates)
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mike Sharland, St. George's Hospital, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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