<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01719510</url>
  </required_header>
  <id_info>
    <org_study_id>P111008</org_study_id>
    <nct_id>NCT01719510</nct_id>
  </id_info>
  <brief_title>Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis</brief_title>
  <acronym>Col-Strepto B</acronym>
  <official_title>Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study : Demonstrate that GBS (group B streptococci) &quot;ST-17&quot;&#xD;
      colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS&#xD;
      non-ST-17.&#xD;
&#xD;
      Secondary objectives:Determine:&#xD;
&#xD;
        -  The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant&#xD;
           women.&#xD;
&#xD;
        -  The frequency of colonization of neonates by GBS ST-17 at birth.&#xD;
&#xD;
        -  The preferential site of colonization in the mother (rectum, vagina, breast milk).&#xD;
&#xD;
        -  The kinetics of colonization after birth in the newborn.&#xD;
&#xD;
        -  The sensitivity and specificity of different GBS detection methods (conventional&#xD;
           phenotypic versus molecular) in the different types of samples from the mother and the&#xD;
           newborn.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women tested positive for GBS during systematic vaginal screening at 35-37 weeks, will be&#xD;
      proposed to participate to the study and will be included after reading the information&#xD;
      letter and signature the consent form.&#xD;
&#xD;
      INCLUSION (D0 at time of delivery)&#xD;
&#xD;
      In the labor ward, two women's groups 1 and 2:&#xD;
&#xD;
      Group 1 = Women tested positive for GBS pre-selected and included in the protocol (see&#xD;
      pre-inclusion) Group 2 = Women without antenatal vaginal screening and at risk of neonatal&#xD;
      infection.&#xD;
&#xD;
      For both groups, at time of delivery:&#xD;
&#xD;
      At the beginning of the labour performed vaginal swabs (PV0):&#xD;
&#xD;
        -  one swab for GBS detection by real-time PCR using the Cepheid technique conducted in the&#xD;
           labor ward by the midwife.&#xD;
&#xD;
        -  the second swab for GBS detection by conventional bacteriological techniques and sent to&#xD;
           the bacteriology laboratory.&#xD;
&#xD;
      For all women included (Group 1 and Group 2 women with a positive GBS vaginal sample) will be&#xD;
      achieved in the delivery room:&#xD;
&#xD;
        1. To the mother: A blood sample of 5 ml at the time of the implementation of the IV line.&#xD;
&#xD;
        2. A sampling of umbilical cord blood. Newborns of mothers included (group 1 and 2) will&#xD;
           have a search for GBS (standard culture) in the stools and the pharynx prior to return&#xD;
           home. Samples will be sent to the bacteriology laboratory and analyzed by classical&#xD;
           bacteriological method (culture) and / or real-time PCR.&#xD;
&#xD;
      For mothers, the collection of 3-5 ml of milk when breastfeeding.&#xD;
&#xD;
      Monitoring schedule:&#xD;
&#xD;
      Day 21 and day 60 post delivery:&#xD;
&#xD;
      the following samples for search of GBS for will be performed to gather the primary endpoint:&#xD;
&#xD;
      For the mother:&#xD;
&#xD;
        -  Vaginal sample.&#xD;
&#xD;
        -  Collection of 3-5 ml of breast milk when breastfeeding&#xD;
&#xD;
      For the newborn:&#xD;
&#xD;
        -  Sample collection of feces&#xD;
&#xD;
        -  Swab of buccal cavity&#xD;
&#xD;
      Processing bacteriological samples:&#xD;
&#xD;
      All samples will be subjected to bacteriological analysis and DNA extraction for detection of&#xD;
      GBS. GBS isolated will be identified and stored at - 80 ° C in a declared biological&#xD;
      collection. DNA extracts will also stored at -20 ° C in a declared biological collection. All&#xD;
      samples for microbiological analysis will be stored at - 80 ° C.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2012</start_date>
  <completion_date type="Actual">June 3, 2015</completion_date>
  <primary_completion_date type="Actual">June 3, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of the hyper-virulent ST17 clone of Group B Strep</measure>
    <time_frame>at 60 days post delivery</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Digestive colonization</measure>
    <time_frame>at day 21</time_frame>
    <description>Digestive colonization of ST17 clone of Group B Strep in the newborns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Milk colonization</measure>
    <time_frame>at day 21 and day 60</time_frame>
    <description>Colonization of milk by ST17 clone of Group B Strep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaginal colonization</measure>
    <time_frame>at day 21 and day 60</time_frame>
    <description>Vaginal colonization by ST17 clone of Group B Strep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late neonatal infections</measure>
    <time_frame>between 3 weeks and 60 days</time_frame>
    <description>Late neonatal infections will be observed between 3 weeks and 60 days</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">949</enrollment>
  <condition>Neonatal Infections Colonize With Group B Streptococci</condition>
  <arm_group>
    <arm_group_label>Positive Group B Streptococcus vaginal sample</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.&#xD;
For all women included will be achieved in the delivery room:&#xD;
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.&#xD;
For mothers, the collection of milk when breastfeeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Samples</intervention_name>
    <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.&#xD;
For both groups:&#xD;
one swab for GBS detection by real-time PCR&#xD;
the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory.&#xD;
For all women included will be achieved in the delivery room:&#xD;
To the mother: A blood sample of 5 ml at the time of the implementation of the IV line.&#xD;
A sampling of umbilical cord blood.&#xD;
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.&#xD;
For mothers, the collection of 3-5 ml of milk when breastfeeding.</description>
    <arm_group_label>Positive Group B Streptococcus vaginal sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +).&#xD;
&#xD;
          -  Patient aged over 18 years&#xD;
&#xD;
          -  Patient who received information and agreeing to sign informed consent&#xD;
&#xD;
          -  Patient affiliated or beneficiary of an insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patient does not speak and does not understand French&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire POYART, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cochin Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Louis Mourier Hospital</name>
      <address>
        <city>Colombes</city>
        <zip>92 700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cochin Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>March 1, 2018</last_update_submitted>
  <last_update_submitted_qc>March 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Group B Streptococcus,</keyword>
  <keyword>Vaginal screening</keyword>
  <keyword>Per partum antibiotic prophylaxis</keyword>
  <keyword>Meningitis</keyword>
  <keyword>Neonatal infection</keyword>
  <keyword>PCR</keyword>
  <keyword>Streptococcus agalactiae.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01719510
org study id: P111008
nct id: NCT01719510
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Detection of the hyper-virulent ST17 clone of Group B Strep
time frame: at 60 days post delivery
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.
measure: Digestive colonization
time frame: at day 21
description: Digestive colonization of ST17 clone of Group B Strep in the newborns
measure: Milk colonization
time frame: at day 21 and day 60
description: Colonization of milk by ST17 clone of Group B Strep
measure: Vaginal colonization
time frame: at day 21 and day 60
description: Vaginal colonization by ST17 clone of Group B Strep
measure: Late neonatal infections
time frame: between 3 weeks and 60 days
description: Late neonatal infections will be observed between 3 weeks and 60 days
arm group label: Positive Group B Streptococcus vaginal sample
arm group type: Other
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: Samples
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.
arm group label: Positive Group B Streptococcus vaginal sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire POYART, MD, PhD
role: Principal Investigator
affiliation: Cochin Hospital
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Meningitis