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

• ClinicalTrials.gov Identifier: NCT01719510
• Recruitment Status: Completed
• First Posted: November 1, 2012
• Last Update Posted: March 2, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: October 30, 2012
• First Posted Date: November 1, 2012
• Last Update Posted Date: March 2, 2018
• Actual Study Start Date: November 12, 2012
• Actual Primary Completion Date: June 3, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2012)

Detection of the hyper-virulent ST17 clone of Group B Strep [ Time Frame: at 60 days post delivery ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01719510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: October 30, 2012)

• Digestive colonization [ Time Frame: at day 21 ]
  Digestive colonization of ST17 clone of Group B Strep in the newborns
• Milk colonization [ Time Frame: at day 21 and day 60 ]
  Colonization of milk by ST17 clone of Group B Strep
• Vaginal colonization [ Time Frame: at day 21 and day 60 ]
  Vaginal colonization by ST17 clone of Group B Strep
• Late neonatal infections [ Time Frame: between 3 weeks and 60 days ]
  Late neonatal infections will be observed between 3 weeks and 60 days

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis
• Official Title: Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B

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:

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Neonatal Infections Colonize With Group B Streptococci

Intervention

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.

Study Arms

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.

Intervention: Other: Samples

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 27, 2016): 949
• Original Estimated Enrollment (submitted: October 30, 2012): 900
• Actual Study Completion Date: June 3, 2015
• Actual Primary Completion Date: June 3, 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01719510
• Other Study ID Numbers: P111008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Claire POYART, MD, PhD; Cochin Hospital

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: February 2018