NeoAMR Observational Study in Neonatal Sepsis

Drugs for Neglected Diseases

Status

Completed

Conditions

Neonatal SEPSIS

Treatments

Other: Main study clinical sepsis

Other: Microbiology sub study

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT03721302

NeoOBS 001

Details and patient eligibility

About

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).

Full description

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.

Enrollment

3,202 patients

Sex

All

Ages

Under 60 days old

Volunteers

No Healthy Volunteers

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