Perinatal GBS and E. coli disease in the Netherlands

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) - Perinatal GBS and E. coli disease in the Netherlands

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52780

Enrollment

750

Registered

2017-08-23

Start date

2018-01-08

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

baby, GBS, group b streptococcal, invasive disease, meningitis and sepsis, neonate, S. agalactiae sepsis, invasive disease, baby, neonate

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Contacts

Public ContactM.W. Bijlsma

Amsterdam UMC

nogbs@amsterdamumc.nl0205661564

Outcome results