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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 (Col-Strepto B)

Primary Purpose

Neonatal Infections Colonize With Group B Streptococci

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Samples
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neonatal Infections Colonize With Group B Streptococci focused on measuring Group B Streptococcus,, Vaginal screening, Per partum antibiotic prophylaxis, Meningitis, Neonatal infection, PCR, Streptococcus agalactiae.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Patient does not speak and does not understand French

Sites / Locations

  • Louis Mourier Hospital
  • Cochin Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Positive Group B Streptococcus vaginal sample

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Digestive colonization
Digestive colonization of ST17 clone of Group B Strep in the newborns
Milk colonization
Colonization of milk by ST17 clone of Group B Strep
Vaginal colonization
Vaginal colonization by ST17 clone of Group B Strep
Late neonatal infections
Late neonatal infections will be observed between 3 weeks and 60 days

Full Information

First Posted
October 30, 2012
Last Updated
March 1, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01719510
Brief Title
Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis
Acronym
Col-Strepto B
Official Title
Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 12, 2012 (Actual)
Primary Completion Date
June 3, 2015 (Actual)
Study Completion Date
June 3, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Women tested positive for GBS during systematic vaginal screening at 35-37 weeks, will be proposed to participate to the study and will be included after reading the information letter and signature the consent form. INCLUSION (D0 at time of delivery) In the labor ward, two women's groups 1 and 2: Group 1 = Women tested positive for GBS pre-selected and included in the protocol (see pre-inclusion) Group 2 = Women without antenatal vaginal screening and at risk of neonatal infection. For both groups, at time of delivery: At the beginning of the labour performed vaginal swabs (PV0): one swab for GBS detection by real-time PCR using the Cepheid technique conducted in the labor ward by the midwife. the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory. For all women included (Group 1 and Group 2 women with a positive GBS vaginal sample) will be achieved in the delivery room: To the mother: A blood sample of 5 ml at the time of the implementation of the IV line. 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. Samples will be sent to the bacteriology laboratory and analyzed by classical bacteriological method (culture) and / or real-time PCR. For mothers, the collection of 3-5 ml of milk when breastfeeding. Monitoring schedule: Day 21 and day 60 post delivery: the following samples for search of GBS for will be performed to gather the primary endpoint: For the mother: Vaginal sample. Collection of 3-5 ml of breast milk when breastfeeding For the newborn: Sample collection of feces Swab of buccal cavity Processing bacteriological samples: All samples will be subjected to bacteriological analysis and DNA extraction for detection of GBS. GBS isolated will be identified and stored at - 80 ° C in a declared biological collection. DNA extracts will also stored at -20 ° C in a declared biological collection. All samples for microbiological analysis will be stored at - 80 ° C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Infections Colonize With Group B Streptococci
Keywords
Group B Streptococcus,, Vaginal screening, Per partum antibiotic prophylaxis, Meningitis, Neonatal infection, PCR, Streptococcus agalactiae.

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
949 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Group B Streptococcus vaginal sample
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Samples
Intervention Description
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: To the mother: A blood sample of 5 ml at the time of the implementation of the IV line. 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.
Primary Outcome Measure Information:
Title
Detection of the hyper-virulent ST17 clone of Group B Strep
Description
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.
Time Frame
at 60 days post delivery
Secondary Outcome Measure Information:
Title
Digestive colonization
Description
Digestive colonization of ST17 clone of Group B Strep in the newborns
Time Frame
at day 21
Title
Milk colonization
Description
Colonization of milk by ST17 clone of Group B Strep
Time Frame
at day 21 and day 60
Title
Vaginal colonization
Description
Vaginal colonization by ST17 clone of Group B Strep
Time Frame
at day 21 and day 60
Title
Late neonatal infections
Description
Late neonatal infections will be observed between 3 weeks and 60 days
Time Frame
between 3 weeks and 60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: - Patient does not speak and does not understand French
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire POYART, MD, PhD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92 700
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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