NeoAMR Observational Study in Neonatal Sepsis

Study Overview
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Brief Summary
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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).

Detailed Description
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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. 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.

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

Conditions
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Neonatal SEPSIS

Intervention / Treatment
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* Other: Main study clinical sepsis
* Other: Microbiology sub study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Study Clinical Sepsis<br>Clinical and Antimicrobial Assessments | Other: Main study clinical sepsis<br>* No intervention-Observational study<br>|
| Microbiology Sub study<br>Clinical and Antimicrobial Assessments | Other: Main study clinical sepsis<br>* No intervention-Observational study<br>Other: Microbiology sub study<br>* Analysis of Bacterial isolates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | 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 | The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates) | 28 days |