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Completed

NCT Number: NCT03371056

Maternal- Fetal Infection

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.

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Key information

Conditions

Neonatal Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Louis Mourier, Colombes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Fetal death or non-viable fetus,
  • maternal age under 18,
  • Patient unable to express her consent,
  • Patient under guardianship.

Treatment and study plan

Bacteriological analyses on clinical samples performed with swabs

Biological

Bacteriological analyses will be performed to assess the InSPIRe kit

Primary outcomes

  1. Presence of Streptococcus B

    Time frame: Day 0

  2. Presence of Streptococcus B

    Time frame: until 20 weeks

Secondary outcomes

  1. Maternal fetal infection

    Time frame: until 20 weeks + 3 days

    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.

  2. A positive bacteriological result in the vaginal sample

    Time frame: Day 0

    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)

  3. A positive bacteriological result in the vaginal sample

    Time frame: until 20 weeks

    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)

  4. Vaginal dysmorphism

    Time frame: day 0

    Defined by lactobacillus's decrease or loss in association with the spread of anaerobic flora.

  5. Vaginal dysmorphism

    Time frame: until 20 weeks

    Defined by lactobacillus's decrease or loss in association with the spread of anaerobic flora.

  6. Antibiotic resistance

    Time frame: Day 0

    Highlighted by a resistant profile in bacteriological culture for various classes of antibiotics such as β-lactamines, macrolides or aminoamides.

  7. Antibiotic resistance

    Time frame: until 20 weeks

    Highlighted by a resistant profile in bacteriological culture for various classes of antibiotics such as β-lactamines, macrolides or aminoamides.

  8. Highlighting specific virulence markers

    Time frame: Day 0

    Like GBS clone CC17, Enterobacteriaceae that produce capsular antigen type K1. By usual molecular techniques.

  9. Highlighting specific virulence markers

    Time frame: until 20 weeks

    Like GBS clone CC17, Enterobacteriaceae that produce capsular antigen type K1. By usual molecular techniques.

  10. Maternal local biomarkers definition

    Time frame: Day 0

    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.

  11. Maternal local biomarkers definition

    Time frame: until 20 weeks

    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.

  12. Bacteriological signature definition

    Time frame: Day 0

    Presence or lack of specific bacteriological sequences detected by global sequencing and metagenomics analyses

  13. Bacteriological signature definition

    Time frame: until 20 weeks

    Presence or lack of specific bacteriological sequences detected by global sequencing and metagenomics analyses

  14. Chorioamnionitis

    Time frame: Day 0

    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.

  15. Chorioamnionitis

    Time frame: until 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • BPIfrance
  • Bforcure
  • Institut Cochin
  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Innovative Strategies for Perinatal Infectious Risk Reduction

Acronym: InSPIRe

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2017
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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