Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China
1 other identifier
observational
150
1 country
1
Brief Summary
Data on neonatal GBS disease are very limited in China. Acceptance and implementation of prevention measures such as antibiotics prevention or vaccination against GBS disease would require robust data. This study as the first national, multicenter study to investigate the epidemiology of GBS disease in China, and the resistance surveillance of GBS isolates, to appraise the necessity of appropriate interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 24, 2016
June 1, 2016
1.6 years
June 13, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of group B streptococcal (GBS) disease
From birth to 3 months of age
Case Fatality Rate of GBS disease
From birth to 3 months of age
GBS serotype distribution
From birth to 3 months of age
Eligibility Criteria
infants \<3 months old born in or treated in a study hospital
You may qualify if:
- Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid.
- ≤90 days old at the time of GBS confirmation.
- Voluntary written informed consent provided.
You may not qualify if:
- \. None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Science Center of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Related Publications (2)
Ji W, Zhou H, Li J, Britto CD, Liu Z, Zhang W, Du J, Madhi SA, Kwatra G, Dangor Z, Jin Z, Zhao H, Zhao Y, Fang Y, Li J. Distributions of candidate vaccine Targets, virulence Factors, and resistance features of invasive group B Streptococcus using Whole-Genome Sequencing: A Multicenter, population-based surveillance study. Vaccine. 2024 Jun 11;42(16):3564-3571. doi: 10.1016/j.vaccine.2024.04.062. Epub 2024 Apr 30.
PMID: 38692955DERIVEDJi W, Liu H, Jin Z, Wang A, Mu X, Qin X, Wang W, Gao C, Zhu Y, Feng X, Lei J, She S, Jiang L, Liu J, Yang S, Liu Z, Li G, Li Q, Guo D, Aziz MM, Gillani AH, Fang Y. Disease burden and antimicrobial resistance of invasive group B streptococcus among infants in China: a protocol for a national prospective observational study. BMC Infect Dis. 2017 May 31;17(1):377. doi: 10.1186/s12879-017-2475-9.
PMID: 28569141DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Haiying Liu, MD, Ph.D
Guangzhou Women and Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Clinical Laboratory
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 24, 2016
Study Start
May 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 24, 2016
Record last verified: 2016-06