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

NCT01719510 | Completed

• 1 other identifier: P111008
• Study Type: interventional
• Target: 949
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17. Secondary objectives:Determine:

• The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women.
• The frequency of colonization of neonates by GBS ST-17 at birth.
• The preferential site of colonization in the mother (rectum, vagina, breast milk).
• The kinetics of colonization after birth in the newborn.
• The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.

Conditions

Neonatal Infections Colonize With Group B Streptococci

Keywords

Group B Streptococcus,; Vaginal screening; Per partum antibiotic prophylaxis; Meningitis; Neonatal infection; PCR; Streptococcus agalactiae.

Outcome Measures

Primary Outcomes (1)

• Detection of the hyper-virulent ST17 clone of Group B Strep

  Detection of the hyper-virulent ST17 clone of Group B Strep (GBS) in the prevention of neonatal GBS meningitis. The main objective is to demonstrate that the hypervirulent ST17 GBS clone colonizing the mother and postpartum acquired colonizes and persists at 60 days post delivery in the gut of new born significantly more than non-ST17 GBS strains.

  at 60 days post delivery

Secondary Outcomes (4)

• Digestive colonization

  at day 21

• Milk colonization

  at day 21 and day 60

• Vaginal colonization

  at day 21 and day 60

• Late neonatal infections

  between 3 weeks and 60 days

Study Arms (1)

Positive Group B Streptococcus vaginal sample

OTHER

At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection. For all women included will be achieved in the delivery room: a blood sample to the mother and a sampling of umbilical cord blood. Newborns will have a search for GBS (standard culture) in the stools and the pharynx. For mothers, the collection of milk when breastfeeding.

Other: Samples

Interventions

Samples OTHER

At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection. For both groups: * one swab for GBS detection by real-time PCR * the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory. For all women included will be achieved in the delivery room: 1. To the mother: A blood sample of 5 ml at the time of the implementation of the IV line. 2. A sampling of umbilical cord blood. Newborns of mothers included (group 1 and 2) will have a search for GBS (standard culture) in the stools and the pharynx prior to return home. For mothers, the collection of 3-5 ml of milk when breastfeeding.

Positive Group B Streptococcus vaginal sample

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +).
• Patient aged over 18 years
• Patient who received information and agreeing to sign informed consent
• Patient affiliated or beneficiary of an insurance

You may not qualify if:

• \- Patient does not speak and does not understand French

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Louis Mourier Hospital

Colombes, 92 700, France

Location

Cochin Hospital

Paris, 75014, France

Location

Related Publications (2)

• Tazi A, Plainvert C, Anselem O, Ballon M, Marcou V, Seco A, El Alaoui F, Joubrel C, El Helali N, Falloukh E, Frigo A, Raymond J, Trieu-Cuot P, Branger C, Le Monnier A, Azria E, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C. Risk Factors for Infant Colonization by Hypervirulent CC17 Group B Streptococcus: Toward the Understanding of Late-onset Disease. Clin Infect Dis. 2019 Oct 30;69(10):1740-1748. doi: 10.1093/cid/ciz033.

  PMID: 30946447 BACKGROUND

• Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert(R) GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29.

  PMID: 29082442 BACKGROUND

MeSH Terms

Conditions

Meningitis

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Claire POYART, MD, PhD

  Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: November 12, 2012
• Primary Completion: June 3, 2015
• Study Completion: June 3, 2015
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (2)