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

Invasive Group B Streptococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812576
• Other study ID #: XJTU-CDSP_01
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 21, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Health Science Center of Xi’an Jiaotong University
• Contact: Wenjing Ji, MS
• Phone: 86+29+82655132
• Email: yfyx_8312[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Days

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Invasive Group B Streptococcal Disease

Locations

Country	Name	City	State
China	Health Science Center of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Health Science Center of Xi’an Jiaotong University	Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of group B streptococcal (GBS) disease		From birth to 3 months of age	No
Primary	Case Fatality Rate of GBS disease		From birth to 3 months of age	No
Primary	GBS serotype distribution		From birth to 3 months of age	No