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Completed

NCT Number: NCT03721302

NeoAMR Observational Study in Neonatal Sepsis

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).

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Key information

Conditions

Neonatal SEPSIS Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

Up to 60 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Dhaka Shishu Hospital, Dhaka, Bangladesh

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Main study clinical sepsis

Other

No intervention-Observational study

Microbiology sub study

Other

Analysis of Bacterial isolates

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Drugs for Neglected Diseases

Other

Collaborators

  • PENTA Foundation
  • St George's, University of London
  • Universiteit Antwerpen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 26, 2018
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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