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

Tracking Information
First Submitted Date ICMJE	October 30, 2012
First Posted Date ICMJE	November 1, 2012
Last Update Posted Date	March 2, 2018
Actual Study Start Date ICMJE	November 12, 2012
Actual Primary Completion Date	June 3, 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01719510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (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 ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis
Official Title ICMJE	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: 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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
Condition ICMJE	Neonatal Infections Colonize With Group B Streptococci
Intervention ICMJE	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: 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.
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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 27, 2016)	949
Original Estimated Enrollment ICMJE; (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 ICMJE	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, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01719510
Other Study ID Numbers ICMJE	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 ICMJE	Assistance Publique - Hôpitaux de Paris
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Claire POYART, MD, PhD Cochin Hospital, India
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP