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NeoAMR Observational Study in Neonatal Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721302
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
St George's, University of London
PENTA Foundation
Universiteit Antwerpen
Information provided by (Responsible Party):
Drugs for Neglected Diseases

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Neonatal SEPSIS Other: Main study clinical sepsis Other: Microbiology sub study

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 Design
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Study Type : Observational
Actual Enrollment : 3202 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Main Study Clinical Sepsis
Clinical and Antimicrobial Assessments
 Other: Main study clinical sepsis
No intervention-Observational study
Microbiology Sub study
Clinical and Antimicrobial Assessments
 Other: Main study clinical sepsis
No intervention-Observational study

Other: Microbiology sub study
Analysis of Bacterial isolates


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Biospecimen Retention:   Samples Without DNA
Microbiological isolates

Eligibility Criteria
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Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized Babies with significant sepsis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721302


Locations
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Sponsors and Collaborators
Drugs for Neglected Diseases
St George's, University of London
PENTA Foundation
Universiteit Antwerpen
Investigators
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Principal Investigator: Mike Sharland St. George's Hospital, University of London
More Information
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Publications:

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Responsible Party: Drugs for Neglected Diseases
ClinicalTrials.gov Identifier: NCT03721302    
Other Study ID Numbers: NeoOBS 001
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Neonatal Sepsis
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Infant, Newborn, Diseases