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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01719510
First received: October 30, 2012
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention
Women at Risk of Neonatal Infections Colonize With GBS (Group B Streptococci).
Other: Samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Detection of the hyper-virulent ST17 clone of Group B Strep [ Time Frame: at 60 days post delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: at day 21 ] [ Designated as safety issue: No ]
    Digestive colonization of ST17 clone of Group B Strep in the newborns

  • Milk colonization [ Time Frame: at day 21 and day 60 ] [ Designated as safety issue: No ]
    Colonization of milk by ST17 clone of Group B Strep

  • Vaginal colonization [ Time Frame: at day 21 and day 60 ] [ Designated as safety issue: No ]
    Vaginal colonization by ST17 clone of Group B Strep

  • Late neonatal infections [ Time Frame: between 3 weeks and 60 days ] [ Designated as safety issue: No ]
    Late neonatal infections will be observed between 3 weeks and 60 days


Estimated Enrollment: 900
Study Start Date: November 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Positive Group B Streptococcus vaginal sample

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

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.


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:

  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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719510

Contacts
Contact: Claire POYART, MD, PhD +33158411560 claire.poyart@cch.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Louis Mourier Hospital Not yet recruiting
Colombes, France, 92 700
Contact: Gilles KAYEM, MD, PHD    + 33 1 47 60 63 39    gkayem@gmail.com   
Principal Investigator: Gilles KAYEM, MD, PhD         
Cochin Hospital Recruiting
Paris, France, 75014
Contact: Claire POYART, MD, PhD    +33158411560    claire.poyart@cch.aphp.fr   
Principal Investigator: Claire POYART, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Claire POYART, MD, PhD Cochin Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01719510     History of Changes
Other Study ID Numbers: P111008
Study First Received: October 30, 2012
Last Updated: July 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Group B Streptococcus,
Vaginal screening
Per partum antibiotic prophylaxis
Meningitis
Neonatal infection
PCR
Streptococcus agalactiae.

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014