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Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection

NCT02471937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2025-09-05

No results posted yet for this study

Summary

Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are defined in neonates by their occurring within or after the first week of life, respectively. Molecular epidemiological studies have identified a capsular serotype III clone, referred to as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal invasive diseases and for almost all cases of meningitis in LOD.

The investigators working hypothesis is that host-environmental interactions may contribute to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this project the investigators will determine if reciprocal interactions between the intestinal microbiota and the innate and adaptive immune system may specifically facilitate the colonization of the neonate by the hypervirulent GBS CC-17 clone.

Conditions

  • Vaginal Colonization With GBS

Interventions

BIOLOGICAL

Bacteriological analyses on clinical samples performed with Eswabs

Clinical samples analysed : mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Claire POYART, MD, PhD, · Assistance Publique Hôpitaux de Paris, Université Paris Descartes

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-04-28
Completion
2016-04-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471937 on ClinicalTrials.gov