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

NCT01719510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 949

Last updated 2025-09-05

No results posted yet for this study

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

Interventions

OTHER

Samples

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.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Claire POYART, MD, PhD · Cochin Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-12
Primary Completion
2015-06-03
Completion
2015-06-03

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 NCT01719510 on ClinicalTrials.gov