Maternal- Fetal Infection (InSPIRe)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Neonatal Infection

Treatments: Biological: Bacteriological analyses on clinical samples performed with swabs

Study type: Interventional

Funder types: Other

Identifiers

NCT03371056

K170907J

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,600 participants in 4 patient groups

Woman at low risk of infection

Experimental group

Description:

Women with systematic vaginal sample for detection of GBS will be included.

Treatment:

Biological: Bacteriological analyses on clinical samples performed with swabs

Woman with high risk of infection > 37 SA

Experimental group

Description:

Women with premature rupture of membranes (\> 12 hours before labor) but \> 37 SA will be included.

Treatment:

Biological: Bacteriological analyses on clinical samples performed with swabs

Women with premature rupture of membranes (<37SA)

Experimental group

Description:

Woman with high risk of infection \<37SA

Treatment:

Biological: Bacteriological analyses on clinical samples performed with swabs

Women with premature delivery or premature delivery threat

Experimental group

Description:

Woman with high risk of infection \<37SA and Women with premature delivery or premature delivery threat

Treatment:

Biological: Bacteriological analyses on clinical samples performed with swabs