Clinical trial NCT02471937: Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
Official title: Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Colonization With GBS
Keywords: Streptococcus agalactiae
Group B Streptococcus
Neonates
colonization
meningitis
Clonal Complex CC17
microbiota
next generation sequencing (NGS)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Negative GBS screening in vaginal samples
timeFrame: 2 months
Secondary outcomes:
measure: Number of Negative GBS screening in fecal samples .
timeFrame: 2 months
measure: Number of Negative GBS screening in fecal samples .
timeFrame: at birth
measure: Number of Negative GBS screening in vaginal samples
timeFrame: At delivery
Other outcomes:
Locations:
city: Colombes
country: France
facility: CH Louis Mourier
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris, Université Paris Descartes
name: Claire POYART, MD, PhD,
role: STUDY_DIRECTOR
References: