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

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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

  • 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).
  • ≤90 days old at the time of GBS confirmation.
  • Voluntary written informed consent provided.

Exclusion criteria

None.

Trial design

10 participants in 1 patient group

Cohort 1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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