NCT03371056

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

December 7, 2017

Last Update Submit

September 26, 2022

Conditions

Neonatal Infection

Keywords

Neonatal infectionsmaternal-fetal infectiongroup B streptococcusvaginal sampleantibiotic prophylaxisbacterial resistance

Outcome Measures

Primary Outcomes (2)

  • Presence of Streptococcus B

    Day 0

  • Presence of Streptococcus B

    until 20 weeks

Secondary Outcomes (15)

  • Maternal fetal infection

    until 20 weeks + 3 days

  • A positive bacteriological result in the vaginal sample

    Day 0

  • A positive bacteriological result in the vaginal sample

    until 20 weeks

  • Vaginal dysmorphism

    day 0

  • Vaginal dysmorphism

    until 20 weeks

  • +10 more secondary outcomes

Study Arms (4)

Woman at low risk of infection

EXPERIMENTAL

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

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.

Biological: Bacteriological analyses on clinical samples performed with swabs

Women with premature rupture of membranes (<37SA)

EXPERIMENTAL

Woman with high risk of infection \<37SA

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

Biological: Bacteriological analyses on clinical samples performed with swabs

Interventions

Bacteriological analyses on clinical samples performed with swabsBIOLOGICAL

Bacteriological analyses will be performed to assess the InSPIRe kit

Woman at low risk of infectionWoman with high risk of infection > 37 SAWomen with premature delivery or premature delivery threatWomen with premature rupture of membranes (<37SA)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Louis Mourier

Colombes, 92700, France

RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

Hopital Bichat

Paris, 75018, France

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26055414BACKGROUND

  • Dussaux 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.

    PMID: 28612662BACKGROUND

  • Kayem 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.

    PMID: 28160689BACKGROUND

  • Lorthe 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.

    PMID: 28081890BACKGROUND

  • Delorme 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.

    PMID: 26646125BACKGROUND

  • Plainvert 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.

    PMID: 29082442BACKGROUND

  • Six 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.

    PMID: 26491182BACKGROUND

Study Officials

  • Laurent Mandelbrot, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Claire Poyart, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

  • Pierre Yves Ancel, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Laurent Mandelbrot, MD, PhD

CONTACT

+33 1 47 60 63 39Laurent.mandelbrot@aphp.fr

Charly LARRIEU

CONTACT

+33 1 58 41 28 99charly.larrieu@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: There are 4 pre-specified groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 13, 2017

Study Start

August 28, 2018

Primary Completion

August 30, 2023

Study Completion

December 30, 2023

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)