PMID- 29371283
OWN - NLM
STAT- MEDLINE
DCOM- 20180817
LR  - 20190202
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 8
IP  - 1
DP  - 2018 Jan 24
TI  - Clinical features, antimicrobial susceptibility patterns and genomics of bacteria 
      causing neonatal sepsis in a children's hospital in Vietnam: protocol for a 
      prospective observational study.
PG  - e019611
LID - 10.1136/bmjopen-2017-019611 [doi]
LID - e019611
AB  - INTRODUCTION: The clinical syndrome of neonatal sepsis, comprising signs of 
      infection, septic shock and organ dysfunction in infants </=4 weeks of age, is a 
      frequent sequel to bloodstream infection and mandates urgent antimicrobial 
      therapy. Bacterial characterisation and antimicrobial susceptibility testing is 
      vital for ensuring appropriate therapy, as high rates of antimicrobial resistance 
      (AMR), especially in low-income and middle-income countries, may adversely affect 
      outcome. Ho Chi Minh City (HCMC) in Vietnam is a rapidly expanding city in 
      Southeast Asia with a current population of almost 8 million. There are limited 
      contemporary data on the causes of neonatal sepsis in Vietnam, and we hypothesise 
      that the emergence of multidrug resistant bacteria is an increasing problem for 
      the appropriate management of sepsis cases. In this study, we aim to investigate 
      the major causes of neonatal sepsis and assess disease outcomes by clinical 
      features, antimicrobial susceptibility profiles and genome composition. METHOD 
      AND ANALYSIS: We will conduct a prospective observational study to characterise 
      the clinical and microbiological features of neonatal sepsis in a major 
      children's hospital in HCMC. All bacteria isolated from blood subjected to whole 
      genome sequencing. We will compare clinical variables and outcomes between 
      different bacterial species, genome composition and AMR gene content. AMR gene 
      content will be assessed and stratified by species, years and contributing 
      hospital departments. Genome sequences will be analysed to investigate 
      phylogenetic relationships. ETHICS AND DISSEMINATION: The study will be conducted 
      in accordance with the principles of the Declaration of Helsinki and the 
      International Council on Harmonization Guidelines for Good Clinical Practice. 
      Ethics approval has been provided by the Oxford Tropical Research Ethics 
      Committee 35-16 and Vietnam Children's Hospital 1 Ethics Committee 73/GCN/BVND1. 
      The findings will be disseminated at international conferences and peer-reviewed 
      journals. TRIAL REGISTRATION NUMBER: ISRCTN69124914; Pre-results.
CI  - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of 
      the article) 2018. All rights reserved. No commercial use is permitted unless 
      otherwise expressly granted.
FAU - Toan, Nguyen Duc
AU  - Toan ND
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
AD  - Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical 
      Medicine, University of Oxford, Oxford, UK.
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
AD  - General planning, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, 
      Vietnam.
FAU - Darton, Thomas C
AU  - Darton TC
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
AD  - Department of Infection, Immunity and Cardiovascular Disease, University of 
      Sheffield Medical School, Sheffield, UK.
FAU - Boinett, Christine J
AU  - Boinett CJ
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
FAU - Campbell, James I
AU  - Campbell JI
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
FAU - Karkey, Abhilasha
AU  - Karkey A
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
FAU - Kestelyn, Evelyne
AU  - Kestelyn E
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
AD  - Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical 
      Medicine, University of Oxford, Oxford, UK.
FAU - Thinh, Le Quoc
AU  - Thinh LQ
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
FAU - Mau, Nguyen Kien
AU  - Mau NK
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
FAU - Thanh Tam, Pham Thi
AU  - Thanh Tam PT
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
FAU - Nhan, Le Nguyen Thanh
AU  - Nhan LNT
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
FAU - Quang Minh, Ngo Ngoc
AU  - Quang Minh NN
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
FAU - Phuong, Cam Ngoc
AU  - Phuong CN
AD  - Hanh Phuc International Hospital, Binh Duong, Vietnam.
FAU - Hung, Nguyen Thanh
AU  - Hung NT
AD  - Intensive care department, Children's Hospital, Ho Chi Minh City, Vietnam.
AD  - General planning, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, 
      Vietnam.
FAU - Xuan, Ngo Minh
AU  - Xuan NM
AD  - General planning, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, 
      Vietnam.
FAU - Thuong, Tang Chi
AU  - Thuong TC
AD  - General planning, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, 
      Vietnam.
AD  - Department of Health, Ho Chi Minh City, Vietnam.
FAU - Baker, Stephen
AU  - Baker S
AD  - Hospital for Tropical Diseases, Wellcome Trust Major Overseas Programme, Oxford 
      University Clinical Research Unit, Ho Chi Minh City, Vietnam.
AD  - Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical 
      Medicine, University of Oxford, Oxford, UK.
AD  - Department of Medicine, University of Cambridge, Cambridge, UK.
LA  - eng
SI  - ISRCTN/ISRCTN69124914
GR  - Wellcome Trust/United Kingdom
GR  - 100087/Z/12/Z/Wellcome Trust/United Kingdom
GR  - 089276/2/09/2/Wellcome Trust/United Kingdom
GR  - SGCL015/1005/Wellcome Trust/United Kingdom
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180124
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - 0 (Anti-Infective Agents)
SB  - IM
MH  - Anti-Infective Agents/*therapeutic use
MH  - Bacteria/*genetics/isolation & purification
MH  - Drug Resistance, Multiple, Bacterial/*genetics
MH  - Female
MH  - Hospitals, Pediatric
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Linear Models
MH  - Male
MH  - Microbial Sensitivity Tests
MH  - Neonatal Sepsis/*drug therapy/*microbiology
MH  - Phylogeny
MH  - Prospective Studies
MH  - Research Design
MH  - Vietnam
MH  - Whole Genome Sequencing
PMC - PMC5786094
OTO - NOTNLM
OT  - antimicrobial resistance
OT  - clinical features
OT  - genomics
OT  - neonates
OT  - outcomes
OT  - sepsis
COIS- Competing interests: None declared.
EDAT- 2018/01/27 06:00
MHDA- 2018/08/18 06:00
PMCR- 2018/01/24
CRDT- 2018/01/27 06:00
PHST- 2018/01/27 06:00 [entrez]
PHST- 2018/01/27 06:00 [pubmed]
PHST- 2018/08/18 06:00 [medline]
PHST- 2018/01/24 00:00 [pmc-release]
AID - bmjopen-2017-019611 [pii]
AID - 10.1136/bmjopen-2017-019611 [doi]
PST - epublish
SO  - BMJ Open. 2018 Jan 24;8(1):e019611. doi: 10.1136/bmjopen-2017-019611.