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

• Conditions: Invasive Group B Streptococcal Disease

• Registration Number: NCT02812576
• Lead Sponsor: Health Science Center of Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-21
• Last Update Submitted: 2016-06-21
• Study First Posted: 2016-06-24
• Last Update Posted: 2016-06-24
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Health Science Center of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China