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
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Condition or disease | Intervention/treatment |
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Neonatal SEPSIS | Other: Main study clinical sepsis Other: Microbiology sub 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.
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 |
Group/Cohort | Intervention/treatment |
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Main Study Clinical Sepsis
Clinical and Antimicrobial Assessments
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Other: Main study clinical sepsis
No intervention-Observational study |
Microbiology Sub study
Clinical and Antimicrobial Assessments
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Other: Main study clinical sepsis
No intervention-Observational study Other: Microbiology sub study Analysis of Bacterial isolates |
- 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).
- 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

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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 |
Inclusion Criteria:
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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:
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• 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

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

Principal Investigator: | Mike Sharland | St. George's Hospital, University of London |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sepsis Toxemia Neonatal Sepsis Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Infant, Newborn, Diseases |