Neonatal InfectionInSPIReNCT03371056
Maternal- Fetal Infection
A study testing Bacteriological analyses on clinical samples performed with swabs in people with Neonatal Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neonatal Infection
- What is being tested?
- Bacteriological analyses on clinical samples performed with swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,569 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Aug 2018to 30 Dec 2023
- 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
- Pregnant woman,
- Gestational age over 22 SA,
- Patient agreeing to sign informed consent,
- Patient aged at least 18 years old,
- Patient with health insurance,
- Singleton, twin or multiple pregnancy.
Who cannot join
- Fetal death or non-viable fetus,
- maternal age under 18,
- Patient unable to express her consent,
- Patient under guardianship.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Louis Mourier
Colombes, 92700
Hôpital Cochin
Paris, 75014
Hopital Bichat
Paris, 75018
About this study
Official title: Innovative Strategies for Perinatal Infectious Risk Reduction
The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.
Read the detailed description
Early-onset neonatal sepsis (EOS) is a major global public health challenge. Prevention during pregnancy and delivery, early diagnosis and treatment of perinatal infections are essential to avoid EOS. Risk factors for include prematurity, maternal Group B streptococcus (GBS) colonization, premature rupture of membranes (PROM), and chorioamnionitis. Screening and intrapartum antimicrobial prophylaxis administered to GBS-colonized women has reduced early onset GBS infections. However, other pathogens are frequently involved in EOS following preterm PROM and preterm birth (PTB), such as Gram-negative bacteria and Staphylococci, which are not covered by penicillin prophylaxis. The prevalence of neonatal infection arising from antibiotic-resistant bacteria is increasing, thus the challenge is to eliminate the widespread unnecessary use of broad-spectrum antibiotics to treat non-infected infants, while recognizing when antibiotics are truly needed. Rapid diagnostic test(s) to detect and quantify specifically pathogens in vaginal samples, could be a major breakthrough. Several rT- PCR ( reverse Transcriptase Polymerase Chain Reaction) tests are on the market, however so far no test is able to detect, quantify and characterize in terms of antibiotic resistance and virulence genes, a range of pathogens.
A novel multiplex platform, using microfluidics technology, is under development by Elvesys, Inc in France. This platform will be able to offer results within 15 minutes on-site.
In addition, the study of the vaginal microbiome may identify signatures associated with a risk of maternal-fetal infection, particularly in case of PROM or PTB. Advanced sequencing technology and metagenomics will be used to characterize these signatures, and may lead to further markers to be included in the point-of-care test. Finally, biomarkers of inflammation will be detected, including IL-6 (Interleukin).
In this study, the InSPIRe platform will be compared in the laboratory to conventional microbiological and immunological detection.
Four groups of pregnant women will be recruited in prospective cohorts : uneventful pregnancies, term PROM, preterm labor and preterm PROM.
The purpose of the InSPIRe project is to improve the prevention of perinatal bacterial infections, with the novel Elvesys point of care system to rapidly detect and characterize microorganisms responsible for neonatal sepsis from a single vaginal sample.
- Conditions
- Neonatal Infection
- Being tested
- Bacteriological analyses on clinical samples performed with swabs
- Keywords
- Neonatal infections, maternal-fetal infection, group B streptococcus, vaginal sample, antibiotic prophylaxis, bacterial resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriological analyses on clinical samples performed with swabsBiological
Bacteriological analyses will be performed to assess the InSPIRe kit
| Study group | Role | What they receive |
|---|---|---|
| Woman at low risk of infection | Experimental | Women with systematic vaginal sample for detection of GBS will be included. Receives: Biological: Bacteriological analyses on clinical samples performed with swabs |
| Woman with high risk of infection > 37 SA | Experimental | Women with premature rupture of membranes (> 12 hours before labor) but > 37 SA will be included. Receives: Biological: Bacteriological analyses on clinical samples performed with swabs |
| Women with premature rupture of membranes (<37SA) | Experimental | Woman with high risk of infection <37SA Receives: Biological: Bacteriological analyses on clinical samples performed with swabs |
| Women with premature delivery or premature delivery threat | Experimental | Woman with high risk of infection <37SA and Women with premature delivery or premature delivery threat Receives: Biological: Bacteriological analyses on clinical samples performed with swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Streptococcus B
Measured: Day 0
Presence of Streptococcus B
Measured: until 20 weeks
Secondary outcomes (15)
Maternal fetal infection
Infection is proved if at least a sample, generally sterile, is positive to a germ in association with a positive clinical, biological or radiologic sign of infection such as C-reactive protein or chest radiography.
Measured: until 20 weeks + 3 days
A positive bacteriological result in the vaginal sample
A positive result is defined as the presence of one of the subsequent germ in the bacteriological culture:
- Escherichia coli (E. coli)
- Streptococcus pneumoniae,
- Group A Streptococcus
- Haemophilus ssp (influenzae, parainfluenzae)
- Staphylococcus aureus
- Streptococcus milleri group
- Enterococcus faecalis
- Other Gram-negative bacilli type enterobacteria (Klebsiella pneumonia, Proteus mirabilis)
- Anaerobics (Prevotella sp, bacteroid fragilis)
Measured: Day 0
A positive bacteriological result in the vaginal sample
A positive result is defined as the presence of one of the subsequent germ in the bacteriological culture:
- Escherichia coli (E. coli)
- Streptococcus pneumoniae,
- Group A Streptococcus
- Haemophilus ssp (influenzae, parainfluenzae)
- Staphylococcus aureus
- Streptococcus milleri group
- Enterococcus faecalis
- Other Gram-negative bacilli type enterobacteria (Klebsiella pneumonia, Proteus mirabilis)
- Anaerobics (Prevotella sp, bacteroid fragilis)
Measured: until 20 weeks
Vaginal dysmorphism
Defined by lactobacillus's decrease or loss in association with the spread of anaerobic flora.
Measured: day 0
Vaginal dysmorphism
Defined by lactobacillus's decrease or loss in association with the spread of anaerobic flora.
Measured: until 20 weeks
Antibiotic resistance
Highlighted by a resistant profile in bacteriological culture for various classes of antibiotics such as β-lactamines, macrolides or aminoamides.
Measured: Day 0
Antibiotic resistance
Highlighted by a resistant profile in bacteriological culture for various classes of antibiotics such as β-lactamines, macrolides or aminoamides.
Measured: until 20 weeks
Highlighting specific virulence markers
Like GBS clone CC17, Enterobacteriaceae that produce capsular antigen type K1. By usual molecular techniques.
Measured: Day 0
Highlighting specific virulence markers
Like GBS clone CC17, Enterobacteriaceae that produce capsular antigen type K1. By usual molecular techniques.
Measured: until 20 weeks
Maternal local biomarkers definition
Presence or lack of RNA sequences and/or human specific protein detected by RT-PCR or ELISA-PCR depending on the presence or lack of a proved or suspected maternal fetal infection.
Measured: Day 0
Maternal local biomarkers definition
Presence or lack of RNA sequences and/or human specific protein detected by RT-PCR or ELISA-PCR depending on the presence or lack of a proved or suspected maternal fetal infection.
Measured: until 20 weeks
Bacteriological signature definition
Presence or lack of specific bacteriological sequences detected by global sequencing and metagenomics analyses
Measured: Day 0
Bacteriological signature definition
Presence or lack of specific bacteriological sequences detected by global sequencing and metagenomics analyses
Measured: until 20 weeks
Chorioamnionitis
Clinical or paraclinical factors associated with risk of chorioamnionitis or maternal fetal infection such as prematurity, clinical signs (maternal fever, fetal tachycardia, increase in C-reactive protein, hyperleukocytosis, pus-like amniotic fluid) , oligohydramnios (defined by the greatest cistern < 25 mm); increase in pro-calcitonin in umbilical cord ok histological signs of placental inflammation.
Clinical chorioamnionitis is defined as a maternal fever> 39° (in one shot) with no other cause or >38°(confirmed) in association with abnormal fetal heartbeat (>160/min exceeding 10 min), maternal hyperleukocytosis (>15000/mm3 without corticotherapy) or pus-like amniotic fluid.
Histological chorioamnionitis is defined by the presence of neutrophil polynuclears in amnion or chorion in association with the presence of neutrophil polynuclears in umbilical cord blood vessels.
Measured: Day 0
Chorioamnionitis
Clinical or paraclinical factors associated with risk of chorioamnionitis or maternal fetal infection such as prematurity, clinical signs (maternal fever, fetal tachycardia, increase in C-reactive protein, hyperleukocytosis, pus-like amniotic fluid) , oligohydramnios (defined by the greatest cistern < 25 mm); increase in pro-calcitonin in umbilical cord ok histological signs of placental inflammation.
Clinical chorioamnionitis is defined as a maternal fever> 39° (in one shot) with no other cause or >38°(confirmed) in association with abnormal fetal heartbeat (>160/min exceeding 10 min), maternal hyperleukocytosis (>15000/mm3 without corticotherapy) or pus-like amniotic fluid.
Histological chorioamnionitis is defined by the presence of neutrophil polynuclears in amnion or chorion in association with the presence of neutrophil polynuclears in umbilical cord blood vessels.
Measured: until 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start28 Aug 2018
- Primary completion30 Aug 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 4 pre-specified groups
- Masking
- None (open label)
- Enrolment
- 2,569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bforcure, BPIfrance, Institut National de la Santé Et de la Recherche Médicale, France, Institut Cochin, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent Mandelbrot, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisClaire Poyart, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisPierre Yves Ancel, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371056
- Sponsor's protocol ID
- K170907J
- Acronym
- InSPIRe
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2017
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joubrel C, Tazi A, Six A, Dmytruk N, Touak G, Bidet P, Raymond J, Trieu Cuot P, Fouet A, Kerneis S, Poyart C. Group B streptococcus neonatal invasive infections, France 2007-2012. Clin Microbiol Infect. 2015 Oct;21(10):910-6. doi: 10.1016/j.cmi.2015.05.039. Epub 2015 Jun 5.
PubMed 26055414Dussaux C, Senat MV, Bouchghoul H, Benachi A, Mandelbrot L, Kayem G. Preterm premature rupture of membranes: is home care acceptable? J Matern Fetal Neonatal Med. 2018 Sep;31(17):2284-2292. doi: 10.1080/14767058.2017.1341482. Epub 2017 Jul 6.
PubMed 28612662Kayem G, Batteux F, Girard N, Schmitz T, Willaime M, Maillard F, Jarreau PH, Goffinet F. Predictive value of vaginal IL-6 and TNFalpha bedside tests repeated until delivery for the prediction of maternal-fetal infection in cases of premature rupture of membranes. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:8-14. doi: 10.1016/j.ejogrb.2017.01.013. Epub 2017 Jan 12.
PubMed 28160689Lorthe E, Ancel PY, Torchin H, Kaminski M, Langer B, Subtil D, Sentilhes L, Arnaud C, Carbonne B, Debillon T, Delorme P, D'Ercole C, Dreyfus M, Lebeaux C, Galimard JE, Vayssiere C, Winer N, L'Helias LF, Goffinet F, Kayem G. Impact of Latency Duration on the Prognosis of Preterm Infants after Preterm Premature Rupture of Membranes at 24 to 32 Weeks' Gestation: A National Population-Based Cohort Study. J Pediatr. 2017 Mar;182:47-52.e2. doi: 10.1016/j.jpeds.2016.11.074. Epub 2017 Jan 9.
PubMed 28081890Delorme P, Goffinet F, Ancel PY, Foix-L'Helias L, Langer B, Lebeaux C, Marchand LM, Zeitlin J, Ego A, Arnaud C, Vayssiere C, Lorthe E, Durrmeyer X, Sentilhes L, Subtil D, Debillon T, Winer N, Kaminski M, D'Ercole C, Dreyfus M, Carbonne B, Kayem G. Cause of Preterm Birth as a Prognostic Factor for Mortality. Obstet Gynecol. 2016 Jan;127(1):40-48. doi: 10.1097/AOG.0000000000001179.
PubMed 26646125Plainvert 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 29082442Six A, Firon A, Plainvert C, Caplain C, Bouaboud A, Touak G, Dmytruk N, Longo M, Letourneur F, Fouet A, Trieu-Cuot P, Poyart C. Molecular Characterization of Nonhemolytic and Nonpigmented Group B Streptococci Responsible for Human Invasive Infections. J Clin Microbiol. 2016 Jan;54(1):75-82. doi: 10.1128/JCM.02177-15. Epub 2015 Oct 21.
PubMed 26491182
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Strategies for Perinatal Infectious Risk Reduction
- ClinicalTrials.gov ID
- NCT03371056
- Acronym / sponsor ID
- InSPIRe / K170907J
- Conditions
- Neonatal Infection
- Keywords
- Neonatal infections, maternal-fetal infection, group B streptococcus, vaginal sample, antibiotic prophylaxis, bacterial resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,569 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bforcure, BPIfrance, Institut National de la Santé Et de la Recherche Médicale, France, Institut Cochin, URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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 purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.
Detailed description
Early-onset neonatal sepsis (EOS) is a major global public health challenge. Prevention during pregnancy and delivery, early diagnosis and treatment of perinatal infections are essential to avoid EOS. Risk factors for include prematurity, maternal Group B streptococcus (GBS) colonization, premature rupture of membranes (PROM), and chorioamnionitis. Screening and intrapartum antimicrobial prophylaxis administered to GBS-colonized women has reduced early onset GBS infections. However, other pathogens are frequently involved in EOS following preterm PROM and preterm birth (PTB), such as Gram-negative bacteria and Staphylococci, which are not covered by penicillin prophylaxis. The prevalence of neonatal infection arising from antibiotic-resistant bacteria is increasing, thus the challenge is to eliminate the widespread unnecessary use of broad-spectrum antibiotics to treat non-infected infants, while recognizing when antibiotics are truly needed. Rapid diagnostic test(s) to detect and quantify specifically pathogens in vaginal samples, could be a major breakthrough. Several rT- PCR ( reverse Transcriptase Polymerase Chain Reaction) tests are on the market, however so far no test is able to detect, quantify and characterize in terms of antibiotic resistance and virulence genes, a range of pathogens.
A novel multiplex platform, using microfluidics technology, is under development by Elvesys, Inc in France. This platform will be able to offer results within 15 minutes on-site.
In addition, the study of the vaginal microbiome may identify signatures associated with a risk of maternal-fetal infection, particularly in case of PROM or PTB. Advanced sequencing technology and metagenomics will be used to characterize these signatures, and may lead to further markers to be included in the point-of-care test. Finally, biomarkers of inflammation will be detected, including IL-6 (Interleukin).
In this study, the InSPIRe platform will be compared in the laboratory to conventional microbiological and immunological detection.
Four groups of pregnant women will be recruited in prospective cohorts : uneventful pregnancies, term PROM, preterm labor and preterm PROM.
The purpose of the InSPIRe project is to improve the prevention of perinatal bacterial infections, with the novel Elvesys point of care system to rapidly detect and characterize microorganisms responsible for neonatal sepsis from a single vaginal sample.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are 4 pre-specified groups
| Arm | Type | Receives |
|---|---|---|
| Woman at low risk of infection | Experimental | Biological: Bacteriological analyses on clinical samples performed with swabsWomen with systematic vaginal sample for detection of GBS will be included. |
| Woman with high risk of infection > 37 SA | Experimental | Biological: Bacteriological analyses on clinical samples performed with swabsWomen with premature rupture of membranes (> 12 hours before labor) but > 37 SA will be included. |
| Women with premature rupture of membranes (<37SA) | Experimental | Biological: Bacteriological analyses on clinical samples performed with swabsWoman with high risk of infection <37SA |
| Women with premature delivery or premature delivery threat | Experimental | Biological: Bacteriological analyses on clinical samples performed with swabsWoman with high risk of infection <37SA and Women with premature delivery or premature delivery threat |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant woman,
- Gestational age over 22 SA,
- Patient agreeing to sign informed consent,
- Patient aged at least 18 years old,
- Patient with health insurance,
Key exclusion criteria (4 listed)
- Fetal death or non-viable fetus,
- maternal age under 18,
- Patient unable to express her consent,
- Patient under guardianship.
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 |
|---|---|---|
| Bacteriological analyses on clinical samples performed with swabsBacteriological analyses will be performed to assess the InSPIRe kit | Biological | Woman at low risk of infection, Woman with high risk of infection > 37 SA, Women with premature delivery or premature delivery threat, Women with premature rupture of membranes (<37SA) |
Primary outcome
Presence of Streptococcus B
Time frame: Day 0
Presence of Streptococcus B
Time frame: until 20 weeks
15 secondary outcomes
Maternal fetal infection
Time frame: until 20 weeks + 3 days
A positive bacteriological result in the vaginal sample
Time frame: Day 0
A positive bacteriological result in the vaginal sample
Time frame: until 20 weeks
Vaginal dysmorphism
Time frame: day 0
Vaginal dysmorphism
Time frame: until 20 weeks
Antibiotic resistance
Time frame: Day 0
Antibiotic resistance
Time frame: until 20 weeks
Highlighting specific virulence markers
Time frame: Day 0
Highlighting specific virulence markers
Time frame: until 20 weeks
Maternal local biomarkers definition
Time frame: Day 0
Maternal local biomarkers definition
Time frame: until 20 weeks
Bacteriological signature definition
Time frame: Day 0
Bacteriological signature definition
Time frame: until 20 weeks
Chorioamnionitis
Time frame: Day 0
Chorioamnionitis
Time frame: until 20 weeks
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 3 Apr 2026.
- Background: PubMed 26055414Joubrel C, Tazi A, Six A, Dmytruk N, Touak G, Bidet P, Raymond J, Trieu Cuot P, Fouet A, Kerneis S, Poyart C. Group B streptococcus neonatal invasive infections, France 2007-2012. Clin Microbiol Infect. 2015 Oct;21(10):910-6. doi: 10.1016/j.cmi.2015.05.039. Epub 2015 Jun 5.
- Background: PubMed 28612662Dussaux C, Senat MV, Bouchghoul H, Benachi A, Mandelbrot L, Kayem G. Preterm premature rupture of membranes: is home care acceptable? J Matern Fetal Neonatal Med. 2018 Sep;31(17):2284-2292. doi: 10.1080/14767058.2017.1341482. Epub 2017 Jul 6.
- Background: PubMed 28160689Kayem G, Batteux F, Girard N, Schmitz T, Willaime M, Maillard F, Jarreau PH, Goffinet F. Predictive value of vaginal IL-6 and TNFalpha bedside tests repeated until delivery for the prediction of maternal-fetal infection in cases of premature rupture of membranes. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:8-14. doi: 10.1016/j.ejogrb.2017.01.013. Epub 2017 Jan 12.
- Background: PubMed 28081890Lorthe E, Ancel PY, Torchin H, Kaminski M, Langer B, Subtil D, Sentilhes L, Arnaud C, Carbonne B, Debillon T, Delorme P, D'Ercole C, Dreyfus M, Lebeaux C, Galimard JE, Vayssiere C, Winer N, L'Helias LF, Goffinet F, Kayem G. Impact of Latency Duration on the Prognosis of Preterm Infants after Preterm Premature Rupture of Membranes at 24 to 32 Weeks' Gestation: A National Population-Based Cohort Study. J Pediatr. 2017 Mar;182:47-52.e2. doi: 10.1016/j.jpeds.2016.11.074. Epub 2017 Jan 9.
- Background: PubMed 26646125Delorme P, Goffinet F, Ancel PY, Foix-L'Helias L, Langer B, Lebeaux C, Marchand LM, Zeitlin J, Ego A, Arnaud C, Vayssiere C, Lorthe E, Durrmeyer X, Sentilhes L, Subtil D, Debillon T, Winer N, Kaminski M, D'Ercole C, Dreyfus M, Carbonne B, Kayem G. Cause of Preterm Birth as a Prognostic Factor for Mortality. Obstet Gynecol. 2016 Jan;127(1):40-48. doi: 10.1097/AOG.0000000000001179.
- Background: 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.
- Background: PubMed 26491182Six A, Firon A, Plainvert C, Caplain C, Bouaboud A, Touak G, Dmytruk N, Longo M, Letourneur F, Fouet A, Trieu-Cuot P, Poyart C. Molecular Characterization of Nonhemolytic and Nonpigmented Group B Streptococci Responsible for Human Invasive Infections. J Clin Microbiol. 2016 Jan;54(1):75-82. doi: 10.1128/JCM.02177-15. Epub 2015 Oct 21.
- Individual participant dataSharing planned: No
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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.
Laurent Mandelbrot, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Claire Poyart, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Pierre Yves Ancel, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacteriological analyses on clinical samples performed with swabs in people with Neonatal Infection, run by Assistance Publique - Hôpitaux de Paris at 3 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 6 inclusion and 4 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Presence of Streptococcus B (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT03371056, which also lists 7 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 3 Apr 2026.