Clinical trial NCT03721302: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal SEPSIS
Lead sponsor: Drugs for Neglected Diseases
Sponsor class: OTHER
Collaborators: name: St George's, University of London
name: PENTA Foundation
name: Universiteit Antwerpen
First posted: 2018-10-26
Enrollment: 3202
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized Babies with significant sepsis

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.

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

Primary outcomes:
measure: Mortality Rate
timeFrame: 28 days
Secondary outcomes:
measure: To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture
timeFrame: 28 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Shishu Hospital
city: São Paulo
country: Brazil
facility: FCM da Santa Casa de São Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
city: Beijing
country: China
facility: Beijing Children Hospital
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital
city: Shenzhen
country: China
facility: Shenzhen Children Hospital
city: Thessaloníki
country: Greece
facility: Hippokration Hospital
city: Mumbai
country: India
facility: King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College
city: New Delhi
country: India
facility: Lady Hardinge Medical College
city: Pondicherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
city: Rome
country: Italy
facility: Bambino Gesu Hospital
city: Kilifi
country: Kenya
facility: KEMRI/Wellcome Trust Research Programme
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
city: Chang Rai
country: Thailand
facility: Chiang Rai Prachanukroh Hospital
city: Kampala
country: Uganda
facility: Mulago Hospital
city: Hanoi
country: Vietnam
facility: Vietnam National Hospital of Paediatrics
Study officials:
affiliation: St. George's Hospital, University of London
name: Mike Sharland
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.