Prospective multicentre observational cohort study on perinatal bacterial infections ;Part 1 of the Netherlands observational study on group B streptococcal disease, bacterial virulence and protective serology (NO GBS)

Recruiting

• Conditions: baby; GBS; group b stretokokkal; invasive disease; meningitis and sepsis; neonate; S. agalactiae; 10004018; 10007951; 10028920

• Registration Number: NL-OMON52780
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

All patients 0-3 months of age with blood or cerebrospinal fluid culture
confirmed invasive GBS or E. coli disease in the Netherlands and their mothers
are eligible for this study.

Exclusion Criteria

Neurosurgical device such as cerebrospinal fluid drain in situ prior to
development of meningitis

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>- Clinical characteristics and outcome parameters<br /><br>- Proportion of cases with risk factors recommended for screening by current<br /><br>and updated Dutch GBS prevention guidelines<br /><br>- Whole genome sequencing of invasive GBS isolates with Illumina HiSeq at the<br /><br>Wellcome Trust Sanger Institute<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>- Comparison of reverse cumulative distributions of specific IgG concentrations<br /><br>determined by enzyme-linked immunosorbent assay (ELISA) against vaccine targets<br /><br>in pregnant women colonized with GBS and mothers of patients with invasive GBS<br /><br>disease<br /><br>- Comparison of reverse cumulative distributions of specific IgG concentrations<br /><br>determined by ELISA against vaccine targets in newborns from pregnant women<br /><br>colonized with GBS (blood spots and cord blood) and patients with invasive GBS<br /><br>disease (blood spots and blood)</p><br>