Neonatal Infections Colonize With Group B StreptococciCol-Strepto BNCT01719510
Interest of the Detection of Hyper-virulent Clone ST17 of Group B Strep (GBS) for the Prevention of Neonatal GBS Meningitis
A study testing Samples in people with Neonatal Infections Colonize With Group B Streptococci, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neonatal Infections Colonize With Group B Streptococci
- What is being tested?
- Samples
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 949 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Nov 2012to 3 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient does not speak and does not understand French
Trial locations and contacts
2 sites in 1 country.
France2 sites
Louis Mourier Hospital
Colombes, 92 700
Cochin Hospital
Paris, 75014
About this study
Official title: Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B
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.
Read the 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.
- Being tested
- Samples
- Keywords
- Group B Streptococcus,, Vaginal screening, Per partum antibiotic prophylaxis, Meningitis, Neonatal infection, PCR, Streptococcus agalactiae.
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
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 group | Role | What they receive |
|---|---|---|
| Positive Group B Streptococcus vaginal sample | Other | 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. Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the hyper-virulent ST17 clone of Group B Strep
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.
Measured: at 60 days post delivery
Secondary outcomes (4)
Digestive colonization
Digestive colonization of ST17 clone of Group B Strep in the newborns
Measured: at day 21
Milk colonization
Colonization of milk by ST17 clone of Group B Strep
Measured: at day 21 and day 60
Vaginal colonization
Vaginal colonization by ST17 clone of Group B Strep
Measured: at day 21 and day 60
Late neonatal infections
Late neonatal infections will be observed between 3 weeks and 60 days
Measured: between 3 weeks and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study start12 Nov 2012
- Primary completion3 Jun 2015
- Study completion3 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal Infections Colonize With Group B StreptococciStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 949 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Claire POYART, MD, PhD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719510
- Sponsor's protocol ID
- P111008
- Acronym
- Col-Strepto B
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2012
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Tazi A, Plainvert C, Anselem O, Ballon M, Marcou V, Seco A, El Alaoui F, Joubrel C, El Helali N, Falloukh E, Frigo A, Raymond J, Trieu-Cuot P, Branger C, Le Monnier A, Azria E, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C. Risk Factors for Infant Colonization by Hypervirulent CC17 Group B Streptococcus: Toward the Understanding of Late-onset Disease. Clin Infect Dis. 2019 Oct 30;69(10):1740-1748. doi: 10.1093/cid/ciz033.
PubMed 30946447Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert(R) GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29.
PubMed 29082442
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B
- ClinicalTrials.gov ID
- NCT01719510
- Acronym / sponsor ID
- Col-Strepto B / P111008
- Keywords
- Group B Streptococcus,, Vaginal screening, Per partum antibiotic prophylaxis, Meningitis, Neonatal infection, PCR, Streptococcus agalactiae.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 949 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Nov 2012 (actual)
- Primary completion
- 3 Jun 2015 (actual)
- Study completion
- 3 Jun 2015 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive Group B Streptococcus vaginal sample | Other | Other: SamplesAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient does not speak and does not understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplesAt 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. | Other | Positive Group B Streptococcus vaginal sample |
Primary outcome
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.
4 secondary outcomes
Digestive colonization
Time frame: at day 21
Milk colonization
Time frame: at day 21 and day 60
Vaginal colonization
Time frame: at day 21 and day 60
Late neonatal infections
Time frame: between 3 weeks and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 30946447Tazi A, Plainvert C, Anselem O, Ballon M, Marcou V, Seco A, El Alaoui F, Joubrel C, El Helali N, Falloukh E, Frigo A, Raymond J, Trieu-Cuot P, Branger C, Le Monnier A, Azria E, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C. Risk Factors for Infant Colonization by Hypervirulent CC17 Group B Streptococcus: Toward the Understanding of Late-onset Disease. Clin Infect Dis. 2019 Oct 30;69(10):1740-1748. doi: 10.1093/cid/ciz033.
- Results publication: PubMed 29082442Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert(R) GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire POYART, MD, PhD principal investigator
Cochin Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples in people with Neonatal Infections Colonize With Group B Streptococci, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the hyper-virulent ST17 clone of Group B Strep (time frame: at 60 days post delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719510, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.