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

Novartis

Status: Completed

Conditions: Invasive Group B Streptococcal Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01933646

V98_23OB

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: Under 90 days old

Volunteers: No 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.

Trial design

10 participants in 1 patient group

Cohort 1