Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China

Burden of Invasive Group B Streptococcal Disease in Infants and Resistance Surveillance in China---A National, Multi-center, Prospective Observational Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02812576

Enrollment

150

Registered

2016-06-24

Start date

2016-05-31

Completion date

2017-12-31

Last updated

2016-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Group B Streptococcal Disease

Keywords

Group B streptococcus, Infants, China

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 90 Days

Healthy volunteers

Inclusion criteria

1. Positive culture for GBS from normally sterile sites such as blood or cerebrospinal fluid. 2. ≤90 days old at the time of GBS confirmation. 3. Voluntary written informed consent provided.

Exclusion criteria

1\. None

Design outcomes

Primary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactWenjing Ji, MS

yfyx_8312@163.com86＋29＋82655132

Backup ContactYu Fang, Ph.D

yufang@mail.xjtu.edu.cn86＋29＋82655132

Outcome results