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NeoAMR Observational Study in Neonatal Sepsis

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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

Tracking Information
First Submitted Date October 4, 2018
First Posted Date October 26, 2018
Last Update Posted Date August 19, 2020
Actual Study Start Date August 16, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 22, 2018)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 29, 2018)
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)
Original Secondary Outcome Measures
 (submitted: October 22, 2018)
Microbiology [ Time Frame: 28 days ]
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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NeoAMR Observational Study in Neonatal Sepsis
Official Title A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Microbiological isolates
Sampling Method Non-Probability Sample
Study Population Hospitalized Babies with significant sepsis
Condition Neonatal SEPSIS
Intervention
  • Other: Main study clinical sepsis
    No intervention-Observational study
  • Other: Microbiology sub study
    Analysis of Bacterial isolates
Study Groups/Cohorts
  • Main Study Clinical Sepsis
    Clinical and Antimicrobial Assessments
    Intervention: Other: Main study clinical sepsis
  • Microbiology Sub study
    Clinical and Antimicrobial Assessments
    Interventions:
    • Other: Main study clinical sepsis
    • Other: Microbiology sub study
Publications * Folgori L, Ellis SJ, Bielicki JA, Heath PT, Sharland M, Balasegaram M. Tackling antimicrobial resistance in neonatal sepsis. Lancet Glob Health. 2017 Nov;5(11):e1066-e1068. doi: 10.1016/S2214-109X(17)30362-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 17, 2020)
3202
Original Estimated Enrollment
 (submitted: October 22, 2018)
3600
Actual Study Completion Date February 29, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 60 Days   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bangladesh,   Brazil,   China,   Greece,   India,   Italy,   Kenya,   South Africa,   Thailand,   Uganda,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT03721302
Other Study ID Numbers NeoOBS 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Drugs for Neglected Diseases
Original Responsible Party Same as current
Current Study Sponsor Drugs for Neglected Diseases
Original Study Sponsor Same as current
Collaborators
  • St George's, University of London
  • PENTA Foundation
  • Universiteit Antwerpen
Investigators
Principal Investigator: Mike Sharland St. George's Hospital, University of London
PRS Account Drugs for Neglected Diseases
Verification Date October 2018