NeoAMR Observational Study in Neonatal Sepsis

• ClinicalTrials.gov Identifier: NCT03721302
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: August 19, 2020
• Sponsor: Drugs for Neglected Diseases
• 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

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.

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

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