Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection (STREPB17)

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Colonization With GBS
• Intervention / Treatment: Biological: Bacteriological analyses on clinical samples performed with Eswabs

Detailed Description

Four specific tasks will be addressed to:

(i) Understand whether and how the gut microbiota may influence growth and colonization of GBS CC-17 within the intestine of neonates.

(ii) Study the contribution of different diets and immune system constituents enabling the persistence of GBS CC-17 in the gut of neonates.

(iii) Determine whether the adaptive immune response elicited by maternal GBS colonization and transmitted to the infant is different for GBS CC-17 versus non-CC-17 GBS.

(iv) Determine whether or not GBS strains isolated from the mothers and from their babies are identical and whether the environment (ie. the vagina or the milk for the mother, the intestine or the oral cavity for the baby) influence the expression of specific virulence factors of CC-17.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92 700
    • CH Louis Mourier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Patient having a negative vaginal swab for GBS at 35-37 weeks
• Patient aged over 18 years
• Patient who received information and agreeing to sign informed consent
• Patient affiliated or beneficiary of an insurance

Exclusion criteria:

• Patient does not speak and does not understand French

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women negative for GBS colonization; Only women negative for GBS during all the study will be included.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Negative GBS screening in vaginal samples	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Negative GBS screening in fecal samples .	2 months
Number of Negative GBS screening in fecal samples .	at birth
Number of Negative GBS screening in vaginal samples	At delivery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Claire POYART, MD, PhD,, Assistance Publique Hôpitaux de Paris, Université Paris Descartes

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): April 28, 2016
• Study Completion (Actual): April 28, 2016

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: meningitis; microbiota; Neonates; colonization; Group B Streptococcus; Streptococcus agalactiae; Clonal Complex CC17; next generation sequencing (NGS)
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2014-A01824-43