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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis

NCT01719510

Neonatal Infections Colonize With Group B Streptococci

COMPLETED NA

Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)

NCT04059510

Group B Streptococcus

UNKNOWN

Streptococcal Infection and Respiratory Distress in Newborns

NCT00612937

Group B Streptococci Respiratory Distress in Newborn

COMPLETED

Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

NCT00326313

Infants With Positive GBS Bacteremia

UNKNOWN

CCA of SGB PCR Versus SGB Culture at 35-38 SA in the Optimization of Intrapartum Antibiotic Prophylaxis

NCT05005169

Streptococcus Agalactiae

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaginal Colonization With GBS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women negative for GBS colonization

Only women negative for GBS during all the study will be included.

Group Type EXPERIMENTAL

Bacteriological analyses on clinical samples performed with Eswabs

Intervention Type BIOLOGICAL

Clinical samples analysed :

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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