- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03721302
NeoAMR Observational Study in Neonatal Sepsis
August 17, 2020 updated by: Drugs for Neglected Diseases
A Prospective, Multinational, Observational, Cohort Study Sepsis in Hospitalised Neonates in Areas With High Endemic Levels of Antimicrobial Resistance.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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
Enrollment (Actual)
3202
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dhaka, Bangladesh
- Dhaka Shishu Hospital
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São Paulo, Brazil
- FCM da Santa Casa de São Paulo
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São Paulo, Brazil
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
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Beijing, China
- Beijing Children hospital
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Beijing, China
- Beijing Obstetrics and Gynecology Hospital
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Shenzhen, China
- Shenzhen Children Hospital
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Thessaloníki, Greece
- Hippokration Hospital
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Mumbai, India
- King Edward Memorial Hospital And Seth Gordhandas Sunderdas Medical College
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New Delhi, India
- Lady Hardinge Medical College
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Pondicherry, India
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
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Rome, Italy
- Bambino Gesu Hospital
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Kilifi, Kenya
- KEMRI/Wellcome Trust Research Programme
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Cape Town, South Africa
- Tygerberg Hospital
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Johannesburg, South Africa
- Charlotte Maxeke
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Johannesburg, South Africa
- Chris Hani Baragwanath Academic hospital
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Bangkok, Thailand
- Queen Sirikit National Institute of Child Health
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Chang Rai, Thailand
- Chiang Rai Prachanukroh Hospital
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Kampala, Uganda
- Mulago Hospital
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Hanoi, Vietnam
- Vietnam National Hospital of Paediatrics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hospitalized Babies with significant sepsis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Main Study Clinical Sepsis
Clinical and Antimicrobial Assessments
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No intervention-Observational study
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Microbiology Sub study
Clinical and Antimicrobial Assessments
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No intervention-Observational study
Analysis of Bacterial isolates
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mortality Rate
Time Frame: 28 days
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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).
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates)
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mike Sharland, St. George's Hospital, University of London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
February 29, 2020
Study Registration Dates
First Submitted
October 4, 2018
First Submitted That Met QC Criteria
October 22, 2018
First Posted (Actual)
October 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 17, 2020
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeoOBS 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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