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.
