Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China: Incidence, Case Fatality Rate and Serotype Distribution

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01933646

Enrollment

Registered

2013-09-02

Start date

2013-09-30

Completion date

2014-09-30

Last updated

2015-01-07

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, Incidence, Case fatality rate, Serotype distribution

Brief summary

Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution

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 one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain). 2. ≤90 days old at the time of GBS confirmation. 3. Voluntary written informed consent provided.

Exclusion criteria

* None.

Design outcomes

Primary

Measure	Time frame
Incidence of group B streptococcal (GBS) disease	From birth to 90 days of age
Case Fatality Rate of GBS disease	From birth to 90 days of age
GBS serotype distribution	From birth to 90 days of age

Countries

China

Outcome results