BMC Infectious Diseases | |
Disease burden and antimicrobial resistance of invasive group B streptococcus among infants in China: a protocol for a national prospective observational study | |
Study Protocol | |
Jing Liu1  Qiuhong Li2  Xiaoping Mu3  Haiying Liu4  Xiaodan Feng5  Xiaosong Qin6  Chunyan Gao7  Jine Lei8  Shangyang She9  Zeshi Liu1,10  Aimin Wang1,11  Lan Jiang1,12  Zhengjiang Jin1,13  Shuhua Yang1,14  Dawen Guo1,15  Weidong Wang1,16  Yuning Zhu1,17  Gang Li1,18  Wenjing Ji1,19  Yu Fang1,19  Muhammad Majid Aziz1,19  Ali Hassan Gillani1,19  | |
[1] Clinical Laboratory, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China;Clinical Laboratory, Chongqing Health Center for Women and Children, Chongqing, China;Clinical Laboratory, Guangdong Women and Children’s Hospital, Guangzhou Medical University, Guangzhou, Guangdong, China;Clinical Laboratory, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong, China;Clinical Laboratory, Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu, China;Clinical Laboratory, Shengjing Hospital, China Medical University, Shenyang, Liaoning, China;Clinical Laboratory, Tangshan Maternal and Child Health Care Hospital, Tangshan, Hebei, China;Clinical Laboratory, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China;Clinical Laboratory, The Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China;Clinical Laboratory, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China;Clinical Microbiology Laboratory, Children’s Hospital of Fudan University, Shanghai, China;Clinical laboratory, Maternal and Child Health Care Hospital of Uygur Autonomous Region, Urumqi, Xinjiang, China;Department of Clinical Laboratory, Hubei Maternal and Child Health Hospital, Wuhan, Hubei, China;Department of Laboratory Medicine, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China;Department of Microbiology, The First Affiliated Hospital, Harbin Medical University, Harbin, Helongjiang, China;Department of Science and Education, Changsha Hospital for Maternal and Child Health, Changsha, Hunan, China;Key Laboratory of Reproductive Genetics (Zhejiang University), Ministry of Education, Clinical Laboratory, Women’s Hospital, Zhejiang University, Zhejiang, Hangzhou, China;Medical Experimental Center, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China;The Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi’an Jiaotong University, 76 Yanta West Road, 710061, Xi’an, Shaanxi, People’s Republic of China;The Center for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, Shaanxi, China;The Global Health Institute, Xi’an Jiaotong University, Xi’an, Shaanxi, China;Shaanxi Center for Health Reform and Development Research, Xi’an, Shaanxi, China; | |
关键词: Group B streptococcus; Incidence; Case fatality ratio; Serotype; Genotype; Antimicrobial resistance; Resistance gene; | |
DOI : 10.1186/s12879-017-2475-9 | |
received in 2016-12-14, accepted in 2017-05-18, 发布年份 2017 | |
来源: Springer | |
【 摘 要 】
BackgroundGroup B Streptococcus (GBS) is a cause of neonatal sepsis, pneumonia, and meningitis that can lead to neurological sequelae in infants less than 3 months of age. The GBS disease burden is not known in China, therefore it cannot receive major attention. The main objectives of this study are the evaluation of the incidence of neonatal GBS infection, GBS case-fatality ratio, its serotypes and genotypes, bacterial resistance, clinical treatment and outcomes in China.MethodsWe are conducting a nation-wide, population-based, multi-center, prospective, observational cohort study in China from May 2016 to December 2017. Eighteen large urban tertiary care hospitals from 16 provinces were selected that cover the eastern, southern, western, northern and central regions of China. Meanwhile, we retrospectively collected data and GBS strains from January 2015 to April 2016 from selected hospitals. The incidence rate per 1000 live births will be defined as the total number of confirmed GBS cases born in the selected hospitals divided by the number of live births in the hospitals during the study period. All GBS cases detected in selected hospitals will be used to calculate the case-fatality ratio and for the typing analysis. GBS isolates will be serotyped using the Strep-B-Latex® rapid latex agglutination test for serotyping of Group B streptococci. Multi-locus sequence typing (MLST) will be performed by sequencing the internal fragments of seven house-keeping genes. Antimicrobial susceptibility will be tested per interpretive standards established by the Clinical and Laboratory Standards Institute. The presence of the common resistance genes ermA, ermB, mefA, tetI, tetO and tetM will be tested by PCR.DiscussionWe are conducting the first national study to estimate the invasive GBS disease burden and antimicrobial resistance of GBS among infants in China. Study findings will provide important evidence for improving clinical practice to ensure timely diagnosis of GBS disease and decisions for preventive measures. Surveillance of antimicrobial resistance will promote the rational use of antimicrobials.Trial registrationThe study was retrospectively registered at http://clinicaltrials.gov on June 13, 2016. It was granted a registration number of “NCT02812576”.
【 授权许可】
CC BY
© The Author(s). 2017
【 预 览 】
Files | Size | Format | View |
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RO202311099468051ZK.pdf | 798KB | download |
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