Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis (Col-Strepto B)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01719510 |
Recruitment Status :
Completed
First Posted : November 1, 2012
Last Update Posted : March 2, 2018
|
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 |
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 | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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:
|
|||
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):
For all women included (Group 1 and Group 2 women with a positive GBS vaginal sample) will be achieved in the delivery room:
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:
For the newborn:
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 ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: N/A 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:
For all women included will be achieved in the delivery room:
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 ICMJE | 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 |
949 | |||
Original Estimated Enrollment ICMJE |
900 | |||
Actual Study Completion Date ICMJE | June 3, 2015 | |||
Actual Primary Completion Date | June 3, 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Patient does not speak and does not understand French |
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | |||
Responsible Party | Assistance Publique - Hôpitaux de Paris | |||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
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 |